Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
810
Countries
12
Sites
41
Melanoma
To compare the efficacy of lifileucel plus pembrolizumab with the efficacy of pembrolizumab alone measured using assessments by the blinded independent review committee (BIRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Key facts
- Sponsor
- Iovance Biotherapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 19 Dec 2025 → ongoing
- Decision date (initial)
- 2023-12-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Iovance Biotherapeutics Inc.
External identifiers
- EU CT number
- 2022-503140-41-00
- ClinicalTrials.gov
- NCT05727904
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Therapy
To compare the efficacy of lifileucel plus pembrolizumab with the efficacy of pembrolizumab alone measured using assessments by the blinded independent review committee (BIRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Secondary objectives 1
- 1. To compare the efficacy of lifileucel plus pembrolizumab with the efficacy of pembrolizumab alone measured using survival2. To compare the efficacy of lifileucel plus pembrolizumab with the efficacy of pembrolizumab alone measured using assessments by the BIRC per RECIST v1.1 3. To compare the efficacy of lifileucel plus pembrolizumab with the efficacy of pembrolizumab alone measured using assessments by the investigator per RECIST v1.1 4. To characterize the safety and tolerability profile of lifileucel plus pembrolizumab and pembrolizumab alone in participants with unresectable or metastatic melanoma
Conditions and MedDRA coding
Melanoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10053571 | Melanoma | 10029104 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment period + Long term Follow up This is a Phase 3 open label extension study. The patients will be randomized on a 1:1 ratio and the study duration will be variable for individual participants. Final analysis of the primary and key secondary endpoints is event driven and depends on when the specified number of OS events has occurred. This is estimated to be approximately 7 years after enrollment begins.
|
Randomised Controlled | None |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 15
- 1. Participant is 18 to 70 years of age at the time of signing the informed consent form
- 2. Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma.
- 3. In the investigator’s assessment, the participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of > 6 months.
- 4. Participant is assessed as having at least one resectable lesion (or aggregate lesions) with an estimated minimum diameter of 1.5 cm for lifileucel generation.
- 5. Participant will have at least one measurable lesion, as defined by RECIST v1.1, at Baseline/cBaseline.
- 6. If the participant has pre-planned surgical procedure(s), the procedure will take place at least 14 days (for major operative procedures) prior to the tumor resection. Wound healing will have occurred, and all complications will have resolved at the time of tumor resection.
- 7. Participant has recovered from all prior anticancer treatment-related AEs to Grade ≤1
- 8. The participant agrees to abide by the following: a. Male Participants: Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 12 months after the last dose of study intervention: • Refrain from donating sperm PLUS, either: − Be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent OR − Must agree to use contraception as detailed below: Agree to use a male condom with female partner use of an additional highly effective contraceptive method with a failure rate of <1% per year as described in Appendix 4. These participants should also be advised of the importance for a female partner of childbearing potential who is not currently pregnant to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse b. Female Participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: Is a woman of nonchildbearing potential (WONCBP) as defined in Appendix 4 OR • Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% Per year) preferably with low user dependency, as described in Appendix 4 during the study intervention period and for at least 12 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure (eg, noncompliance, recently initiated) in relationship to the first dose of study intervention. • A WOCBP must have a negative serum or urine pregnancy test within 24 hours before the tumor resection. • Additional requirements for pregnancy testing during and after study intervention are located in Section 8.3.8 • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- 9. Participant is capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol and the understanding that there are other FDA approved therapies for advanced melanoma and, if randomized to the lifileucel regimen, there may be a need for intensive supportive care measures.
- 10. Participant provided written authorization for use and disclosure of protected health information.
- 11. Participant has the following hematologic parameters: • ANC ≥1000/mm3 or ≥1 × 109/L • Hemoglobin ≥8.0 g/dL or ≥4.96 mmol/L • Platelet count ≥100,000/mm3 or ≥100 × 109/L
- 12. Participant has adequate organ function with the following laboratory values: • Serum ALT and AST ≤3 × ULN; participants with liver metastasis may have ALT and AST ≤5 × ULN • Total bilirubin ≤2 mg/dL; participants with Gilbert’s Syndrome may have total bilirubin ≤3 mg/dL • Estimated CrCl ≥40 mL/min using the Cockcroft-Gault formula
- 13. Participant has an LVEF >45% and is NYHA Class 1. For participants ≥60 years of age
- 14. A participant who meets any of the following criteria must achieve either a FEV1/FVC >70% or FEV1 >50% with or without a bronchodilator:: • Has a history of cigarette smoking of ≥20 pack-years • Ceased smoking within the past 2 years or continues to smoke • Has a history of COPD • Has any signs or symptoms of respiratory dysfunction • Has a history of pleural drainage within the past 3 months
- 15. Participant is willing to receive optimal supportive care, including intensive care, from enrollment until the first post treatment tumor assessment.
Exclusion criteria 12
- 1. Participant has melanoma of uveal/ocular origin.
- 2. Participant has symptomatic untreated brain metastases. Participants with brain metastases may be evaluated for study participation with the following considerations and only after dicussion with the medical monitor : • Participants with asymptomatic brain metastases not newly diagnosed at Screening and who do not clinically require treatment may be considered for study participation. • A participant with historically treated brain metastases (ie, treatment was completed >28 days prior to consenting for study participation) may be considered for study participation if the participant is clinically stable for ≥2 weeks, there are no new or worsening brain lesions via screening MRI, and the participant does not require ongoing corticosteroid treatment (>10 mg/day prednisone or equivalent). • If there are progressive or new brain metastases on the screening MRI, the participant should first receive treatment for them prior to restarting or continuing screening. A participant with recently treated brain metastases (ie, treatment of brain metastases was completed ≤28 days prior to consenting for study participation) may be considered for study participation if the participant is asymptomatic, clinically stable for ≥2 weeks, and does not require corticosteroids (>10 mg/day prednisone or equivalent). Repeat brain imaging is not required after treatment; however, brain imaging is required at Baseline.
- 3. Participant received any of the following previous therapies: • Participant received prior therapy for metastatic disease • Participants with a BRAF V600 mutation-positive tumor received prior adjuvant/neoadjuvant ICI therapy only
- 4. Participant has an active medical illness(es) that, in the opinion of the investigator, would pose increased risks for study participation, such as systemic infections; seizure disorders; coagulation disorders; or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.
- 5. Participant has active uveitis that requires active treatment. Participants with a history of uveitis must have an eye examination performed by a trained eye specialist at Screening to rule out active uveitis that requires treatment.
- 6. Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS).
- 7. Participant has a history of hypersensitivity to any component of the study intervention, including, but not limited to, any of the following: • NMA-LD (cyclophosphamide, mesna, and fludarabine) • Proleukin®, aldesleukin, IL-2 • Antibiotics of the aminoglycoside group (ie, streptomycin, gentamicin). These participants may be eligible if current hypersensitivity has been excluded. • Any component of the lifileucel product formulation, including DMSO, HSA, IL-2, or dextran 40 • Pembrolizumab
- 8. Participant had another primary malignancy within the previous 3 years (except for those that do not require treatment or were curatively treated >1 year ago, and in the judgment of the investigator do not pose a significant risk of recurrence including, but not limited to, non-melanoma skin cancer, DCIS, LCIS, prostate cancer Gleason score ≤6, or superficial bladder cancer)
- 9. Participant has a history of allogeneic cell or organ transplant.
- 10. Participant requires systemic steroid therapy >10 mg/day of prednisone or another steroid equivalent dose.
- 11. Participant received or will receive a live or attenuated vaccination within 28 days prior to the start of study medication.
- 12. Participant has evidence of any active viral, bacterial, or fungal infection requiring ongoing systemic treatment or that is identified during screening
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PFS is defined as the time from the date of randomization until disease progression assessed by the BIRC per RECIST v1.1 or death due to any cause
Secondary endpoints 1
- OS is defined as the time from the date of randomization to death due to any cause
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323784 · Product
- Active substance
- Pembrolizumab
- Substance synonyms
- Lambrolizumab, MK-3475, SCH-900475, ABP 234
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/19/2243
- Modified vs. Marketing Authorisation
- No
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD12081132 · Product
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/003
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323786 · Product
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD12081135 · Product
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/003
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10381997 · Product
- Active substance
- Lifileucel
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 100000000000 DF dosage form
- Max total dose
- 100000000000 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- IOVANCE BIOTHERAPEUTICS, INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 4
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323105 · Product
- Active substance
- Pembrolizumab
- Substance synonyms
- Lambrolizumab, MK-3475, SCH-900475, ABP 234
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/19/2243
- Modified vs. Marketing Authorisation
- No
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD12081133 · Product
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/003
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD12081134 · Product
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/003
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323785 · Product
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 17
SUB07678MIG · Substance
- Active substance
- Fludarabine
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 25 mg/m2 milligram(s)/sq. meter
- Max total dose
- 125 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fludarabine Phosphate 25 mg/ml Concentrate for Solution for Injection or Infusion
PRD786717 · Product
- Active substance
- Fludarabine Phosphate
- Substance synonyms
- FLUDARABINE 5'-MONOPHOSPHATE, FLUDARABINE MONOPHOSPHATE
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 25 mg/m2 milligram(s)/sq. meter
- Max total dose
- 125 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- PL 00289/0938
- MA holder
- TEVA UK LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Флударабин Актавис 25 mg/ml концентрат за инжекционен или инфузионен разтвор
PRD930525 · Product
- Active substance
- Fludarabine Phosphate
- Substance synonyms
- FLUDARABINE 5'-MONOPHOSPHATE, FLUDARABINE MONOPHOSPHATE
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 25 mg/m2 milligram(s)/square meter
- Max total dose
- 125 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- 20100674
- MA holder
- TEVA PHARMA EAD
- MA country
- Bulgaria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fludarabine - PCH 25 mg/ml, concentraat voor oplossing voor intraveneuze infusie of injectie
PRD732137 · Product
- Active substance
- Fludarabine Phosphate
- Substance synonyms
- FLUDARABINE 5'-MONOPHOSPHATE, FLUDARABINE MONOPHOSPHATE
- Pharmaceutical form
- INJECTION
- Route of administration
- INFUSION
- Max daily dose
- 25 mg/m2 milligram(s)/sq. meter
- Max total dose
- 125 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- RVG 33255
- MA holder
- PHARMACHEMIE BV
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fludarabine phosphate 25 mg/ml Concentrate for Solution for Injection or Infusion
PRD1794909 · Product
- Active substance
- Fludarabine Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 25 mg/m2 milligram(s)/sq. meter
- Max total dose
- 125 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- PL 20075/0379
- MA holder
- ACCORD HEALTHCARE LIMITED
- MA country
- United Kingdom
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fludarabine Teva 25 mg/ml solution à diluer pour injection ou perfusion
PRD3852415 · Product
- Active substance
- Fludarabine Phosphate
- Substance synonyms
- FLUDARABINE 5'-MONOPHOSPHATE, FLUDARABINE MONOPHOSPHATE
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 25 mg/m2 milligram(s)/sq. meter
- Max total dose
- 125 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- BE303721
- MA holder
- TEVA PHARMA BELGIUM N.V./S.A
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fludarabine Accord 25 mg/ml koncentratas injekciniam ar infuziniam tirpalui
PRD1794902 · Product
- Active substance
- Fludarabine Phosphate
- Substance synonyms
- FLUDARABINE 5'-MONOPHOSPHATE, FLUDARABINE MONOPHOSPHATE
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 25 mg/m2 milligram(s)/sq. meter
- Max total dose
- 125 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- LT/1/14/3627/001
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Lithuania
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fludarabine Teva 25 mg/ml concentraat voor oplossing voor injectie of infusie
PRD745724 · Product
- Active substance
- Fludarabine Phosphate
- Substance synonyms
- FLUDARABINE 5'-MONOPHOSPHATE, FLUDARABINE MONOPHOSPHATE
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 25 mg/m2 milligram(s)/sq. meter
- Max total dose
- 125 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- BE303721
- MA holder
- TEVA PHARMA BELGIUM N.V./S.A
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fludarabina Teva 25 mg/ml concentrado para solución para perfusión o inyección EFG
PRD664775 · Product
- Active substance
- Fludarabine Phosphate
- Substance synonyms
- FLUDARABINE 5'-MONOPHOSPHATE, FLUDARABINE MONOPHOSPHATE
- Pharmaceutical form
- INJECTION
- Route of administration
- INFUSION
- Max daily dose
- 25 mg/m2 milligram(s)/sq. meter
- Max total dose
- 125 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- 69052
- MA holder
- TEVA PHARMA S.L.U.,
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PROLEUKIN® 18 x 106 IU Powder for solution for injection or infusion
PRD11346174 · Product
- Active substance
- Aldesleukin
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 60000 IU/Kg iu/kilogram
- Max total dose
- 3600000 IU/Kg iu/kilogram
- Max treatment duration
- 4 Day(s)
- Authorisation status
- Authorised
- ATC code
- L03AC01 — ALDESLEUKIN
- Marketing authorisation
- PL 59077/0001
- MA holder
- IOVANCE BIOTHERAPEUTICS B.V
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Proleukin 18 x 106 IE Poeder voor oplossing voor injectie of infusie
PRD11294442 · Product
- Active substance
- Aldesleukin
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 60000 IU/Kg iu/kilogram
- Max total dose
- 3600000 IU/Kg iu/kilogram
- Max treatment duration
- 4 Day(s)
- Authorisation status
- Authorised
- ATC code
- L03AC01 — ALDESLEUKIN
- Marketing authorisation
- RVG 13354
- MA holder
- IOVANCE BIOTHERAPEUTICS B.V
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08784MIG · Substance
- Active substance
- Mesna
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 240 mg/m2 milligram(s)/sq. meter
- Max total dose
- 480 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08784MIG · Substance
- Active substance
- Mesna
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 240 mg/m2 milligram(s)/sq. meter
- Max total dose
- 480 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Endoxan 1000 mg milteliai injekciniam tirpalui
PRD349512 · Product
- Active substance
- Cyclophosphamide Monohydrate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFUSION
- Max daily dose
- 60 mg/kg milligram(s)/kilogram
- Max total dose
- 120 mg/kg milligram(s)/kilogram
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AA01 — CYCLOPHOSPHAMIDE
- Marketing authorisation
- LT/1/97/3087/004
- MA holder
- UAB “BAXTER LITHUANIA”
- MA country
- Lithuania
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cyclophosphamide Injection 1 g
PRD347230 · Product
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFUSION
- Max daily dose
- 60 mg/kg milligram(s)/kilogram
- Max total dose
- 120 mg/kg milligram(s)/kilogram
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AA01 — CYCLOPHOSPHAMIDE
- Marketing authorisation
- PL 00116/0388
- MA holder
- BAXTER HEALTHCARE LTD.
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD11980406 · Product
- Active substance
- Cyclophosphamide Monohydrate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFUSION
- Max daily dose
- 60 mg/kg milligram(s)/kilogram
- Max total dose
- 120 mg/kg milligram(s)/kilogram
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AA01 — CYCLOPHOSPHAMIDE
- Marketing authorisation
- 6035903.00.00
- MA holder
- BAXTER DEUTSCHLAND GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cyclophosphamide 1000 mg Powder for Solution for Injection or Infusion
PRD1649381 · Product
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 60 mg/kg milligram(s)/kilogram
- Max total dose
- 120 mg/kg milligram(s)/kilogram
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AA01 — CYCLOPHOSPHAMIDE
- Marketing authorisation
- PL 04416/1394
- MA holder
- SANDOZ LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Iovance Biotherapeutics Inc.
- Sponsor organisation
- Iovance Biotherapeutics Inc.
- Address
- 825 Industrial Road Suite 100
- City
- San Carlos
- Postcode
- 94070-3303
- Country
- United States
Scientific contact point
- Organisation
- Iovance Biotherapeutics Inc.
- Contact name
- Himani Parikh
Public contact point
- Organisation
- Iovance Biotherapeutics Inc.
- Contact name
- Iovance
Third parties 11
| Organisation | City, country | Duties |
|---|---|---|
| Perceptive Informatics Inc. ORG-100013171
|
Burlington, United States | On site monitoring, Other |
| Imperial Clinical Research Services (CRS) ORL-000002396
|
Grand Rapids, United States | Other |
| Quipment ORG-100043496
|
Nancy, France | Other |
| Pharmaceutical Product Development LLC ORG-100016999
|
Highland Heights, United States | Laboratory analysis |
| Ppd Inc. ORG-100018960
|
Wilmington, United States | On site monitoring, Code 10, Code 11, Code 12, Code 5, Data management, E-data capture |
| Precision for Medicine GmbH ORG-100044456
|
Berlin, Germany | Laboratory analysis |
| Syneos Health UK Limited ORG-100008519
|
Farnborough, United Kingdom | Code 8 |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
| PPD Global Central Labs (S) Pte Ltd ORG-100041754
|
Singapore, Singapore | Laboratory analysis |
| PPD Global Ltd. ORG-100007531
|
Marousi, Greece | Other |
| PPD International Holdings LLC ORG-100007655
|
Zaventem, Belgium | Laboratory analysis |
Locations
12 EU/EEA countries · 41 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 25 | 1 |
| Czechia | Ended | 5 | 1 |
| Finland | Authorised, recruiting | 5 | 1 |
| France | Authorised, recruiting | 45 | 3 |
| Germany | Ongoing, recruiting | 35 | 7 |
| Greece | Ended | 10 | 2 |
| Italy | Ongoing, recruiting | 70 | 5 |
| Netherlands | Ongoing, recruiting | 5 | 1 |
| Poland | Ended | 10 | 2 |
| Slovenia | Ended | 5 | 1 |
| Spain | Ongoing, recruiting | 70 | 16 |
| Sweden | Ongoing, recruiting | 5 | 1 |
| Rest of world
Switzerland, United Kingdom, Israel, Singapore, Australia, Canada, Korea, Republic of, United States
|
— | 520 | — |
Investigational sites
Fakultni Nemocnice Hradec Kralove
Klinika onkologie a radioterapie, Sokolska 581, Novy Hradec Kralove, Hradec Kralove
Hospital Hotel Dieu
Dermatology department, 1 Place Alexis Ricordeau, 44000, Nantes
Hopital Saint Louis
Dermatology department, 1 Avenue Claude Vellefaux, 75010, Paris
Institut Paoli Calmettes
n/a, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Universitaetsklinikum Schleswig-Holstein
Dermatology, Ratzeburger Allee 160, 23538, Lübeck
Klinikum rechts der Isar der TU Muenchen AöR
Klinik und Poliklinik für Innere Medizin III Hämatologie/Onkologie, Ismaninger Strasse 22, Au-Haidhausen, Munich
LMU Klinikum Muenchen AöR
Klinik und Poliklinik für Dermatologie und Allergologie, Frauenlobstrasse 9-11, Ludwigsvorstadt-Isarvorstadt, Munich
Charite Universitaetsmedizin Berlin KöR
Department of Hematology, Oncology and Cancer Immunology, Hindenburgdamm 30, Lichterfelde, Berlin
University Medical Center Hamburg-Eppendorf
Department of Dermatology and Venereology University Skin Cancer Center Hamburg, Martinistrasse 52, Eppendorf, Hamburg
Universitätsklinikum Würzburg
Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Hautkrebszentrum, Josef-Schneider-Str. 2, 97080, Würzburg
Technische Universitaet Dresden
Medizinische Fakultät Carl Gustav Carus Early Clinical Trial Unit (NCT/UCC ECTU), Fetscherstrasse 74, Johannstadt-Nord, Dresden
Laiko General Hospital Of Athens
1 st Department of Medicine, Agiou Thoma (goudi) 17, 115 27, Athens
General University Hospital Of Patras
Hematology Unit – Clinic of Internal Medicine, Rio, 265 04, Patras
Centro Di Riferimento Oncologico Di Aviano
SOC di Oncologia medica e prevenzione oncologica, Via Franco Gallini 2, 33081, Aviano
Azienda Ospedaliera Universitaria Senese
U.O.C. Immunoterapia oncologica, Strada Delle Scotte 14, 53100, Siena
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
UO Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Dipartimento CORP-S di Ricerca ed Assistenziale Cute, Melanoma Immunologia Oncologica, Via Mariano Semmola 52, 80131, Naples
Azienda Ospedaliero Universitaria Pisana
U.O. di Oncologia Medica, Via Roma 67, 56126, Pisa
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Center of Cellular Therapy, Plesmanlaan 121, 1066 CX, Amsterdam
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Oddzial Onkologii Klinicznej, Ul. Dra Kazimierza Jaczewskiego 7, 20-090, Lublin
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Tkanek Miękkich, Kości i Czerniaków, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Clinica Universidad De Navarra
Oncology, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Virgen De La Macarena
Medical Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitari Dexeus Grupo Quironsalud
Medical Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital Universitario Hm Sanchinarro
Oncology, Calle Ona 10, 28050, Madrid
Hospital Universitario 12 De Octubre
Medical Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario Regional De Malaga
Medical Oncology, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Universitario Ramon Y Cajal
Medical Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Marques De Valdecilla
Medical Oncology, Avenida Valdecilla Sn, 39008, Santander
Hospital General Universitario De Valencia
Oncology, Avenida Del Tres Cruces 2, 46014, Valencia
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital General Universitario Gregorio Maranon
Medical Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Marques De Valdecilla
Medical Oncology, Avenida Valdecilla Sn, 39008, Santander
Institut Catala D'oncologia
Infectious Diseases Unit, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2024-11-29 | 2025-03-20 | |||
| Finland | 2025-10-10 | ||||
| France | 2024-04-18 | ||||
| Germany | 2024-07-12 | 2024-08-15 | |||
| Italy | 2024-04-18 | 2024-04-29 | |||
| Netherlands | 2024-03-11 | 2024-04-29 | |||
| Spain | 2024-01-22 | 2024-02-20 | |||
| Sweden | 2024-03-25 | 2024-04-09 | |||
| Czechia | |||||
| Greece | |||||
| Poland | |||||
| Slovenia |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 8 · Art. 38 CTR
Temporary halt TH-108607
- Halt date
- 2025-11-11
- Planned restart
- 2025-12-19
- Member states concerned
- France
- Publication date
- 2025-11-28
- Reason
- Sponsor decision, Medicinal Product related, Study management related
- Explanation
- We are writing to notify you of scheduled routine annual maintenance activities at our iCTC manufacturing facility, which requested investigators to temporarily and briefly pause the identification and screening of new potential clinical trial patients. Importantly, the brief pause in the identification of new potential clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This notification is being provided should the brief scheduled routine maintenance activities at iCTC and resulting temporary pause in identification of new potential clinical trial patients effectuate any notification or reporting obligations pertaining to this trial.Clinical trials sites were notified of the upcoming temporary pausing of identification of new trial patients on November 11, 2025. Clinical trial participants who were consented and are currently in screening will all complete their screening activities and undergo tumor resection by December 4, 2025. Identification of new clinical trial participants will resume on December 19, 2025. All study procedures are continuing per protocol during the annual maintenance for all participants who have signed informed consents across all of our clinical trials.
Again, this temporary pause for identification of new clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This pause of identification of new clinical trial patients is solely to perform our routine planned annual maintenance for GMP compliance. - Follow-up measures
- n/a
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-108606
- Halt date
- 2025-11-11
- Planned restart
- 2025-12-19
- Member states concerned
- Germany
- Publication date
- 2025-11-28
- Reason
- Medicinal Product related, Study management related, Sponsor decision
- Explanation
- We are writing to notify you of scheduled routine annual maintenance activities at our iCTC manufacturing facility, which requested investigators to temporarily and briefly pause the identification and screening of new potential clinical trial patients. Importantly, the brief pause in the identification of new potential clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This notification is being provided should the brief scheduled routine maintenance activities at iCTC and resulting temporary pause in identification of new potential clinical trial patients effectuate any notification or reporting obligations pertaining to this trial.Clinical trials sites were notified of the upcoming temporary pausing of identification of new trial patients on November 11, 2025. Clinical trial participants who were consented and are currently in screening will all complete their screening activities and undergo tumor resection by December 4, 2025. Identification of new clinical trial participants will resume on December 19, 2025. All study procedures are continuing per protocol during the annual maintenance for all participants who have signed informed consents across all of our clinical trials.
Again, this temporary pause for identification of new clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This pause of identification of new clinical trial patients is solely to perform our routine planned annual maintenance for GMP compliance. - Follow-up measures
- n/a
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-108609
- Halt date
- 2025-11-11
- Planned restart
- 2025-12-19
- Member states concerned
- Belgium
- Publication date
- 2025-11-28
- Reason
- Sponsor decision, Medicinal Product related, Study management related
- Explanation
- We are writing to notify you of scheduled routine annual maintenance activities at our iCTC manufacturing facility, which requested investigators to temporarily and briefly pause the identification and screening of new potential clinical trial patients. Importantly, the brief pause in the identification of new potential clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This notification is being provided should the brief scheduled routine maintenance activities at iCTC and resulting temporary pause in identification of new potential clinical trial patients effectuate any notification or reporting obligations pertaining to this trial.Clinical trials sites were notified of the upcoming temporary pausing of identification of new trial patients on November 11, 2025. Clinical trial participants who were consented and are currently in screening will all complete their screening activities and undergo tumor resection by December 4, 2025. Identification of new clinical trial participants will resume on December 19, 2025. All study procedures are continuing per protocol during the annual maintenance for all participants who have signed informed consents across all of our clinical trials.
Again, this temporary pause for identification of new clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This pause of identification of new clinical trial patients is solely to perform our routine planned annual maintenance for GMP compliance. - Follow-up measures
- n/a
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-108608
- Halt date
- 2025-11-11
- Planned restart
- 2025-12-19
- Member states concerned
- Netherlands
- Publication date
- 2025-11-28
- Reason
- Sponsor decision, Medicinal Product related, Study management related
- Explanation
- We are writing to notify you of scheduled routine annual maintenance activities at our iCTC manufacturing facility, which requested investigators to temporarily and briefly pause the identification and screening of new potential clinical trial patients. Importantly, the brief pause in the identification of new potential clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This notification is being provided should the brief scheduled routine maintenance activities at iCTC and resulting temporary pause in identification of new potential clinical trial patients effectuate any notification or reporting obligations pertaining to this trial.Clinical trials sites were notified of the upcoming temporary pausing of identification of new trial patients on November 11, 2025. Clinical trial participants who were consented and are currently in screening will all complete their screening activities and undergo tumor resection by December 4, 2025. Identification of new clinical trial participants will resume on December 19, 2025. All study procedures are continuing per protocol during the annual maintenance for all participants who have signed informed consents across all of our clinical trials.
Again, this temporary pause for identification of new clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This pause of identification of new clinical trial patients is solely to perform our routine planned annual maintenance for GMP compliance. - Follow-up measures
- n/a
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-108605
- Halt date
- 2025-11-11
- Planned restart
- 2025-12-19
- Member states concerned
- Sweden
- Publication date
- 2025-11-28
- Reason
- Sponsor decision, Medicinal Product related, Study management related
- Explanation
- We are writing to notify you of scheduled routine annual maintenance activities at our iCTC manufacturing facility, which requested investigators to temporarily and briefly pause the identification and screening of new potential clinical trial patients. Importantly, the brief pause in the identification of new potential clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This notification is being provided should the brief scheduled routine maintenance activities at iCTC and resulting temporary pause in identification of new potential clinical trial patients effectuate any notification or reporting obligations pertaining to this trial.Clinical trials sites were notified of the upcoming temporary pausing of identification of new trial patients on November 11, 2025. Clinical trial participants who were consented and are currently in screening will all complete their screening activities and undergo tumor resection by December 4, 2025. Identification of new clinical trial participants will resume on December 19, 2025. All study procedures are continuing per protocol during the annual maintenance for all participants who have signed informed consents across all of our clinical trials.
Again, this temporary pause for identification of new clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This pause of identification of new clinical trial patients is solely to perform our routine planned annual maintenance for GMP compliance. - Follow-up measures
- n/a
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-108604
- Halt date
- 2025-11-11
- Planned restart
- 2025-12-19
- Member states concerned
- Italy
- Publication date
- 2025-11-28
- Reason
- Sponsor decision, Medicinal Product related, Study management related
- Explanation
- We are writing to notify you of scheduled routine annual maintenance activities at our iCTC manufacturing facility, which requested investigators to temporarily and briefly pause the identification and screening of new potential clinical trial patients. Importantly, the brief pause in the identification of new potential clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This notification is being provided should the brief scheduled routine maintenance activities at iCTC and resulting temporary pause in identification of new potential clinical trial patients effectuate any notification or reporting obligations pertaining to this trial.Clinical trials sites were notified of the upcoming temporary pausing of identification of new trial patients on November 11, 2025. Clinical trial participants who were consented and are currently in screening will all complete their screening activities and undergo tumor resection by December 4, 2025. Identification of new clinical trial participants will resume on December 19, 2025. All study procedures are continuing per protocol during the annual maintenance for all participants who have signed informed consents across all of our clinical trials.
Again, this temporary pause for identification of new clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This pause of identification of new clinical trial patients is solely to perform our routine planned annual maintenance for GMP compliance. - Follow-up measures
- n/a
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-108610
- Halt date
- 2025-11-11
- Planned restart
- 2025-12-19
- Member states concerned
- Spain
- Publication date
- 2025-11-28
- Reason
- Sponsor decision, Medicinal Product related, Study management related
- Explanation
- We are writing to notify you of scheduled routine annual maintenance activities at our iCTC manufacturing facility, which requested investigators to temporarily and briefly pause the identification and screening of new potential clinical trial patients. Importantly, the brief pause in the identification of new potential clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This notification is being provided should the brief scheduled routine maintenance activities at iCTC and resulting temporary pause in identification of new potential clinical trial patients effectuate any notification or reporting obligations pertaining to this trial.Clinical trials sites were notified of the upcoming temporary pausing of identification of new trial patients on November 11, 2025. Clinical trial participants who were consented and are currently in screening will all complete their screening activities and undergo tumor resection by December 4, 2025. Identification of new clinical trial participants will resume on December 19, 2025. All study procedures are continuing per protocol during the annual maintenance for all participants who have signed informed consents across all of our clinical trials.
Again, this temporary pause for identification of new clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This pause of identification of new clinical trial patients is solely to perform our routine planned annual maintenance for GMP compliance. - Follow-up measures
- n/a
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-108611
- Halt date
- 2025-11-11
- Planned restart
- 2025-12-19
- Member states concerned
- Finland
- Publication date
- 2025-11-28
- Reason
- Sponsor decision, Medicinal Product related, Study management related
- Explanation
- We are writing to notify you of scheduled routine annual maintenance activities at our iCTC manufacturing facility, which requested investigators to temporarily and briefly pause the identification and screening of new potential clinical trial patients. Importantly, the brief pause in the identification of new potential clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This notification is being provided should the brief scheduled routine maintenance activities at iCTC and resulting temporary pause in identification of new potential clinical trial patients effectuate any notification or reporting obligations pertaining to this trial.Clinical trials sites were notified of the upcoming temporary pausing of identification of new trial patients on November 11, 2025. Clinical trial participants who were consented and are currently in screening will all complete their screening activities and undergo tumor resection by December 4, 2025. Identification of new clinical trial participants will resume on December 19, 2025. All study procedures are continuing per protocol during the annual maintenance for all participants who have signed informed consents across all of our clinical trials.
Again, this temporary pause for identification of new clinical trial patients is not due to safety or clinical observations in any of our clinical trials and will not impact the integrity of the trials. This pause of identification of new clinical trial patients is solely to perform our routine planned annual maintenance for GMP compliance. - Follow-up measures
- n/a
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Unexpected events 1 · Art. 53 CTR
Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.
Unexpected event UE-116334
- Event date
- 2026-01-20
- Date aware
- 2026-01-20
- Submission date
- 2026-01-26
- Member states affected
- Italy, Sweden, Germany, France, Netherlands, Belgium, Spain, Czechia, Greece, Finland, Poland, Slovenia
- Event description
- The administration of the product is necessary to avoid an immediate and significant hazard to the patient. Alternative options for the patient have been considered including the potential consequences of not receiving the product. The deviation(s) associated with the lot means that the lot’s specific ability or capacity to achieve the intended therapeutic effect may be impaired.
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-FR-0001
- Member state
- France
- Publication date
- 2025-10-29
- Type
- 3
- Reason
- 7
- Immediate action required
- Yes
- Justification
- Following assessment of response of RFI-CT-2022-503140-41-00-SM12-008-01: It is acknowledged that in some centers in Europe, lymphodepletion can be performed in an outpatient setting but in France patients eligible to receive the whole treatement regimen, i.e.NMA-LD regimen, lifilieucel and IL-2, are hospitalized accorditing to cyclophosphamide SmPC in which it is stated in section 4.2 that Cyclophosphamide should only be administered where there are facilities for regular monitoring of clinical, biochemical and haematological parameters before, during, and after administration and under the direction of a specialist oncology service . Therefore the protocol should be modified in order to add the following as follows: In France patients should be hospitalized from the initiation of nonmyeloablative lymphodepletion (NMA-LD) until they have completed the IL-2 (aldesleukin) treatment and have recovered from any serious side effects associated with the AMTAGVI treatment regimen
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 192 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Iovance_IOV-MEL-301_Protocol Clarification letter memo 2 for V3_2022-503140-41-00_Public | n/a |
| Protocol (for publication) | D1_Iovance_IOV-MEL-301_Protocol_2022-503140-41-00_GRC_Public | 4.0 |
| Protocol (for publication) | D1_Iovance_IOV-MEL-301_Protocol_2022-503140-41-00_Public | 4.1 |
| Protocol (for publication) | D1_Iovance_IOV-MEL-301_Protocol_Clarification Memo 1_2022-503140-41-00_Public | 3 |
| Protocol (for publication) | D4_IOV_MEL-301_Patient Materials_POL_Public | n/a |
| Protocol (for publication) | D4_IOV_MEL-301_Patient Materials_SVN_Public | n/a |
| Protocol (for publication) | D4_IOV-MEL-301_Country PC_BE_Dutch_Public | 3.0 |
| Protocol (for publication) | D4_IOV-MEL-301_Country PC_BE_French_Public | 3.0 |
| Protocol (for publication) | D4_IOV-MEL-301_Country PC_BE_German_Public | 3.0 |
| Protocol (for publication) | D4_IOV-MEL-301_Country PC_DE_German_Public | 3.0 |
| Protocol (for publication) | D4_IOV-MEL-301_Country PC_FR_French_Public | 3.0 |
| Protocol (for publication) | D4_IOV-MEL-301_Country PC_IT_English_Public | 3.0 |
| Protocol (for publication) | D4_IOV-MEL-301_Country PC_IT_Italian_Public | 3.0 |
| Protocol (for publication) | D4_IOV-MEL-301_Country PC_NL_Dutch_Public | 2.0.0 |
| Protocol (for publication) | D4_IOV-MEL-301_Country PC_SE_Swedish_Public | 3.0 |
| Protocol (for publication) | D4_IOV-MEL-301_EQ-5D-5L_BE_Dutch_Public | 1.2 |
| Protocol (for publication) | D4_IOV-MEL-301_EQ-5D-5L_BE_French_Public | 1.1 |
| Protocol (for publication) | D4_IOV-MEL-301_EQ-5D-5L_BE_German_Public | 1.1 |
| Protocol (for publication) | D4_IOV-MEL-301_EQ-5D-5L_DE_German_Public | 1.0 |
| Protocol (for publication) | D4_IOV-MEL-301_EQ-5D-5L_FR_French_Public | 1.2 |
| Protocol (for publication) | D4_IOV-MEL-301_EQ-5D-5L_IT_Italian_Public | 1.1 |
| Protocol (for publication) | D4_IOV-MEL-301_EQ-5D-5L_NL_Dutch_Public | 1.1 |
| Protocol (for publication) | D4_IOV-MEL-301_EQ-5D-5L_SW_Swedish_Public | 1.1 |
| Protocol (for publication) | D4_IOV-MEL-301_Patient Materials_CZE_Public | n/a |
| Protocol (for publication) | D4_IOV-MEL-301_Patient Materials_GRC_Public | n/a |
| Protocol (for publication) | D4_IOV-MEL-301_QLQ-C30_Dutch_Public | 3.0 |
| Protocol (for publication) | D4_IOV-MEL-301_QLQ-C30_English_Public | 3.0 |
| Protocol (for publication) | D4_IOV-MEL-301_QLQ-C30_French_Public | 3.0 |
| Protocol (for publication) | D4_IOV-MEL-301_QLQ-C30_IT_English_Public | 3.0 |
| Protocol (for publication) | D4_IOV-MEL-301_QLQ-C30_IT_Italian_Public | 3.0 |
| Protocol (for publication) | D4_IOV-MEL-301_QLQ-C30_SE_Swedish_Public | 3.0 |
| Protocol (for publication) | D4_IOV-MEL-301-Patient Materials_FIN_Public | n/a |
| Protocol (for publication) | D4_Iovance_IOV-MEL-301_Country PC_CZE_CZ_Public | 3.0 |
| Protocol (for publication) | D4_Iovance_IOV-MEL-301_Country PC_CZE_EN_Public | 3.0 |
| Protocol (for publication) | D4_Iovance_IOV-MEL-301_Country PC_ES_Spanish_Public | 3.0 |
| Protocol (for publication) | D4_Iovance_IOV-MEL-301_Country PC_ESP_EN_Public | 3.0 |
| Protocol (for publication) | D4_Iovance_IOV-MEL-301_Country PC_FIN_FI_Public | 3.0 |
| Protocol (for publication) | D4_Iovance_IOV-MEL-301_Country PC_FRA_ EN_Public | 3.0 |
| Protocol (for publication) | D4_Iovance_IOV-MEL-301_Country PC_GRC_EN_Public | 3.0 |
| Protocol (for publication) | D4_Iovance_IOV-MEL-301_Country PC_GRC_GR_Public | 3.0 |
| Protocol (for publication) | D4_Iovance_IOV-MEL-301_Country PC_POL_PL_Public | 3.0 |
| Protocol (for publication) | D4_Iovance_IOV-MEL-301_Country PC_SLV_EN_Public | 3.0 |
| Protocol (for publication) | D4_Iovance_IOV-MEL-301_Country PC_SLV_SL_Public | 3.0 |
| Protocol (for publication) | D4_Iovance_IOV-MEL-301_eCRF Completion_Guidelines_LN-144_Public | 2.0 |
| Protocol (for publication) | D4_Iovance_IOV-MEL-301_EQ-5D-5L_ES_Spanish_Public | 1.0 |
| Protocol (for publication) | D4_Iovance_IOV-MEL-301_Image Acquisition Guideline IAG_LN-144_Public | 1.0 |
| Protocol (for publication) | D4_Iovance_IOV-MEL-301_PfM Laboratory Manual Ex-US_LN-144_Public | 1.0 |
| Protocol (for publication) | D4_Iovance_IOV-MEL-301_Pharmacy Manual_Ex-US_LN-144_Public | 1.0 |
| Protocol (for publication) | D4_Iovance_IOV-MEL-301_QLQ-C30_DEU_DE_Public | 3.0 |
| Protocol (for publication) | D4_Iovance_IOV-MEL-301_QLQ-C30_ES_Spanish_Public | 1.1 |
| Protocol (for publication) | D4_Iovance_IOV-MEL-301_Tumor Procurement and Shipping Manual_Ex-US_LN-144_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_IOV-MEL-301_Informed Consent Flowchart_FR_French_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_IOV-MEL-301_Recruitment and Informed Consent Procedure_FIN_Finnish_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_IOV-MEL-301_Recruitment_Arrangements_ES_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_IOV-MEL-301_Recruitment_Arrangements_FR_French_Public | 1 |
| Recruitment arrangements (for publication) | K1_IOV-MEL-301_Recruitment_Informed_Consent_Procedure_FR_French_Public | 2 |
| Recruitment arrangements (for publication) | K1_IOV-MEL-301_Recruitment-and-Informed-Consent-Procedure_DE_English_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_IOV-MEL-301_Recruitment-Arrangements_BE_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_IOV-MEL-301_Recruitment-Arrangements_CZ_English_Public | N/A |
| Recruitment arrangements (for publication) | K1_IOV-MEL-301_Recruitment-Arrangements_GRC_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_IOV-MEL-301_Recruitment-Arrangements_IT_CL_Public | 2.1 |
| Recruitment arrangements (for publication) | K1_IOV-MEL-301_Recruitment-Arrangements_NL_English_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_IOV-MEL-301_Recruitment-arrangements_SI_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_IOV-MEL-301_Recruitment-Arrangements_SWE_Swedish_Public | N/A |
| Recruitment arrangements (for publication) | K1_IOV-MEL-301_Recruitment-Informed_Consent_Procedure_PL_Polish_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_IOV-MEL-301_GP Letter_IT_Italian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_IOV-MEL-301_Informed Consent Flowchart_CZ_Czech_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_IOV-MEL-301_Informed Consent Flowchart_FIN_Finnish_Public | 1.2 |
| Recruitment arrangements (for publication) | K2_IOV-MEL-301_Informed Consent Flowchart_GRC_Greek_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_IOV-MEL-301_Informed_Consent_Flowchart_ITA_Italian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_IOV-MEL-301_Informed-Consent_Flowchart_ES_Spanish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_IOV-MEL-301_Informed-Consent-Flowchart_BE_Dutch_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_IOV-MEL-301_Informed-Consent-Flowchart_BE_French_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_IOV-MEL-301_Informed-Consent-Flowchart_BE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_IOV-MEL-301_Informed-Consent-Flowchart_NL_Dutch_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_IOV-MEL-301_Informed-Consent-Flowchart_PL_Polish_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_IOV-MEL-301_Informed-Consent-Flowchart_SI_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_IOV-MEL-301_Informed-Consent-Flowchart_SWE_Swedish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_IOV-MEL-301_Informed-Consent-Flowchart_US_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_IOV-MEL-301_Inforrmed-Consent-Flowchart_DE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_IOV-MEL-301_Patient_Card_FR_French_Public | 2.0.0 |
| Subject information and informed consent form (for publication) | IOV-MEL-301_EU CTR_BEL_PART II_IN_Response-to-Conditional-Approval_ENG_FINAL | n/a |
| Subject information and informed consent form (for publication) | L_IOV-MEL-301_Genetic Sub-Study_ICF_ES_Spanish_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301 _Crossover_ICF_CZ_Czech_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301 _Main_ICF_CZ_Czech_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301 _Pregant-partner_ICF_CZ_Czech_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Arm B Crossover ICF_FIN_Finnish_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Arm-B-Crossover-ICF_DE_German_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Crossover ICF_GRC_English_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Crossover ICF_GRC_Greek_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Crossover_ICF_ESP_SPA_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Crossover_ICF_IT_Italian_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Crossover-ICF_BEL_DEU_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Crossover-ICF_BEL_ENG_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Crossover-ICF_BEL_FRA_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Crossover-ICF_BEL_NLD_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Crossover-ICF_FR_French_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Crossover-ICF_PL_Polish_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Crossover-ICF_SI_Slovenian_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Crossover-ICF_SWE_Swedish_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Main ICF_FIN_Finnish_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Main ICF_FR_French_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Main ICF_GRC_English_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Main ICF_GRC_Greek_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Main_ICF_ESP_SPA_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Main_ICF_IT_Italian_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Main-ICF_BEL_DEU_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Main-ICF_BEL_ENG_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Main-ICF_BEL_FRA_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Main-ICF_BEL_NLD_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Main-ICF_DE_German_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Main-ICF_PL_Polish_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Main-ICF_SI_Slovenian_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Main-ICF_SWE_Swedish_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_OOS ICF_BE_DUT_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_OOS ICF_BE_ENG_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_OOS ICF_BE_FRE_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_OOS ICF_BE_GER_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_OOS ICF_FIN_Finnish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_OOS ICF_FR_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_OOS ICF_GRC_Greek_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_OOS ICF_Swe_Swedish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_OOS_ICF_ CZ_Czech_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_OOS_ICF_ES_Spanish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_OOS_ICF_ITA_Italian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Opt Genetic Sub-Study ICF_FIN_Finnish_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Opt Post-Prog Tumor Tissue Biopsy Sub-Study ICF_FIN_Finnish_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Opt Post-Treat Tumor Tissue Biopsy Sub-Study ICF_FIN_Finnish_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Opt_Genetic_Sub-Study_ICF_IT_Italian_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Optional Genetic Research ICF_GRC_English_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Optional Genetic Research ICF_GRC_Greek_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Optional Genetic Research Sub-Study Consent_DE_German_Clean_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Optional Post Progression ICF_GRC_English_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Optional Post Progression ICF_GRC_Greek_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Optional Post Treatment ICF_GRC_English_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Optional Post Treatment ICF_GRC_Greek_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Optional Post-Progression Biopsy Sub-Study ICF_DE_German_clean_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Optional Post-Treatment Biopsy Sub-Study ICF_DE_German_clean_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Optional_Sub-Study_ICF_IT_Italian_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Optional-Genetic-Research- Sub-Study _ICF_CZ_Czech_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Optional-Post-Progression-Tumor-Tissue-Biopsy-Sub-Study _ICF_CZ_Czech_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Optional-Post-Treatment-Tumor-Tissue-Biopsy-Sub-Study _ICF_CZ_Czech_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Out-of-specification_ICF_PL_Polish_clean_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Out-of-Specification-ICF_DE_German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Out-of-Specification-ICF_SI_Slovenian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Personal-Data-Protection-Sheet_ CZ_Czech_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_PP-ICF_PL_Polish_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Preg Partic Preg Partner Newborn ICF_GRC_English_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Preg Partic Preg Partner Newborn ICF_GRC_Greek_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Pregnant Participant or Pregnant Partner_ICF_FR_French_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Pregnant partner ICF_FIN_Finnish_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Pregnant Partner_ICF_IT_Italian_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Pregnant_Partner_and_Newborn_Parents_ICF_ES_Spanish_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Pregnant-Participant-ICF_DE_German_clean_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Pregnant-Partner-ICF_DE_German_Clean_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Pregnant-Partner-ICF_SI_Slovenian_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Pregnant-Partner-ICF_SWE_Swedish_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Privacy_Addendum_ICF_IT_Italian_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_SIS-and-ICF_Genetic-substudy_NL_Dutch_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_SIS-and-ICF_Main_NL_Dutch_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_SIS-and-ICF_OOS-Addendum_NL_Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_SIS-and-ICF_Pregnant-Partner-ICF_NL_Dutch_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_SIS-and-ICF_Tumor-tissue-biopsy-sub-study_NL_Dutch_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_SIS-and-ICF-Crossover-ICF_NL_Dutch_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_IOV-MEL-301_Sponsor_Statement_Main-ICF_BEL_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_lOV-MEL-301_Pregnant-Partner-ICF_BE_Dutch_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_lOV-MEL-301_Pregnant-Partner-ICF_BE_English_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_lOV-MEL-301_Pregnant-Partner-ICF_BE_French_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_lOV-MEL-301_Pregnant-Partner-ICF_BE_German_Public | 4.0 |
| Subject information and informed consent form (for publication) | L2_IOV-MEL-301_Patient-card_CZ_Czech_Public | 2.0.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Iovance_IOV-MEL-301_SmPC_Pembrolizumab_GBR | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Iovance_IOV-MEL-301_SmPC_Pembrolizumab_GBR | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Iovance_IOV-MEL-301_SmPC_Pembrolizumab_NLD | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Iovance_IOV-MEL-301_SmPC_Pembrolizumab_NLD | n/a |
| Synopsis of the protocol (for publication) | D1_Iovance_IOV-MEL-301_Protocol Lay Summary_2022-503140-41-00_BE_French_Public | 3.1 |
| Synopsis of the protocol (for publication) | D1_IOVANCE_IOV-MEL-301_Protocol Lay Summary_2022-503140-41-00_ES_Public | 3.1 |
| Synopsis of the protocol (for publication) | D1_Iovance_IOV-MEL-301_Protocol Synopsis_2022-503140-41-00_CZE_Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_Iovance_IOV-MEL-301_Protocol Synopsis_2022-503140-41-00_ES_Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_Iovance_IOV-MEL-301_Protocol Synopsis_2022-503140-41-00_GRC_Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_Iovance_IOV-MEL-301_Protocol Synopsis_2022-503140-41-00_SVN_Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_Iovance_IOV-MEL-301_Protocol_Lay_Summary_2022-503140-41_SVN_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_Iovance_IOV-MEL-301_Protocol_Lay_Summary_2022-503140-41-00_BEL_DE_Public | 3.1 |
| Synopsis of the protocol (for publication) | D1_Iovance_IOV-MEL-301_Protocol_Lay_Summary_2022-503140-41-00_BEL_NL_Public | 3.1 |
| Synopsis of the protocol (for publication) | D1_Iovance_IOV-MEL-301_Protocol_Lay_Summary_2022-503140-41-00_CZE_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_Iovance_IOV-MEL-301_Protocol_Lay_Summary_2022-503140-41-00_ENG_Public | 3.1 |
| Synopsis of the protocol (for publication) | D1_Iovance_IOV-MEL-301_Protocol_Lay_Summary_2022-503140-41-00_FRE_Public | 3.1 |
| Synopsis of the protocol (for publication) | D1_Iovance_IOV-MEL-301_Protocol_Lay_Summary_2022-503140-41-00_GRC_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_Iovance_IOV-MEL-301_Protocol_Lay_Summary_2022-503140-41-00_ITA_Public | 3.1 |
| Synopsis of the protocol (for publication) | D1_Iovance_IOV-MEL-301_Protocol_Lay_Summary_2022-503140-41-00_NDL_Public | 3.1 |
| Synopsis of the protocol (for publication) | D1_Iovance_IOV-MEL-301_Protocol_Lay_Summary_2022-503140-41-00_POL_Public | 3.0 |
| Synopsis of the protocol (for publication) | D1_Iovance_IOV-MEL-301_Protocol_Lay_Summary_2022-503140-41-00_SWE_Public | 3.1 |
| Synopsis of the protocol (for publication) | D1_Iovance_IOV-MEL-301_Protocol_synopsis_2022-503140-41-00_ITA_Public | 4.1 |
Application history
30 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-21 | Spain | Acceptable 2023-12-11
|
2023-12-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-12-20 | Acceptable 2023-12-11
|
2023-12-20 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-01-12 | Spain | Acceptable 2023-12-11
|
2024-01-12 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-15 | Acceptable | 2024-03-01 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-01-31 | Acceptable | 2024-03-15 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-03-25 | 2024-03-25 | ||
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-05-02 | Spain | 2024-05-02 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-05-07 | Acceptable | 2024-06-07 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-05-07 | Acceptable | 2024-07-04 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-05-07 | Acceptable | 2024-06-26 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-05-07 | Spain | Acceptable | 2024-05-29 |
| 12 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-09-13 | Spain | Acceptable with conditions 2025-01-08
|
2025-01-08 |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-01-22 | Acceptable with conditions 2025-01-08
|
2025-01-22 | |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-01-24 | Spain | Acceptable with conditions 2025-01-08
|
2025-01-24 |
| 15 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-02-05 | Acceptable with conditions | 2025-03-20 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-02-05 | Acceptable with conditions | 2025-03-11 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-02-11 | Acceptable with conditions | 2025-03-31 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-02-12 | Spain | Acceptable with conditions | 2025-03-03 |
| 19 | SUBSEQUENT ADDITION OF MSC | APP-19 | 2025-02-26 | 2025-05-20 | ||
| 20 | SUBSEQUENT ADDITION OF MSC | APP-20 | 2025-02-26 | Acceptable with conditions 2025-01-08
|
2025-05-13 | |
| 21 | SUBSEQUENT ADDITION OF MSC | APP-21 | 2025-02-26 | 2025-05-19 | ||
| 22 | SUBSEQUENT ADDITION OF MSC | APP-22 | 2025-02-26 | Acceptable with conditions 2025-01-08
|
2025-05-26 | |
| 23 | SUBSEQUENT ADDITION OF MSC | APP-23 | 2025-02-26 | Acceptable with conditions 2025-01-08
|
2025-04-17 | |
| 24 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2025-06-03 | Acceptable with conditions 2025-01-08
|
2025-06-03 | |
| 25 | NON SUBSTANTIAL MODIFICATION | NSM-9 | 2025-06-16 | Acceptable with conditions 2025-01-08
|
2025-06-16 | |
| 26 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-07-11 | Spain | Acceptable 2025-10-21
|
2025-10-22 |
| 27 | NON SUBSTANTIAL MODIFICATION | NSM-10 | 2025-10-30 | Acceptable 2025-10-21
|
2025-10-30 | |
| 28 | NON SUBSTANTIAL MODIFICATION | NSM-11 | 2025-10-31 | Spain | Acceptable 2025-10-21
|
2025-10-31 |
| 29 | SUBSTANTIAL MODIFICATION | SM-13 | 2025-12-19 | Spain | Acceptable 2026-04-13
|
2026-04-14 |
| 30 | NON SUBSTANTIAL MODIFICATION | NSM-12 | 2026-04-28 | Acceptable 2026-04-13
|
2026-04-28 |