Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
30
Countries
1
Sites
1
Metastatic non-clear cell renal cell carcinoma
To analyse the overall response rate, ORR (complete + partial response) in the total population based on RECIST (v1.1) criteria. To analyse time to treatment failure in the total population.
Key facts
- Sponsor
- Region Hovedstaden
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 6 Mar 2020 → 18 Mar 2026
- Decision date (initial)
- 2024-10-31
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-519070-39-00
- EudraCT number
- 2019-001316-38
- ClinicalTrials.gov
- NCT04644432
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Therapy, Others, Pharmacoeconomic
To analyse the overall response rate, ORR (complete + partial response) in the total population based on RECIST (v1.1) criteria.
To analyse time to treatment failure in the total population.
Secondary objectives 1
- To calculate progression-free survival for the total population. To calculate overall survival for the total population. To calculate disease control rate, DCR (complete response + partial response + stabile disease) for the total population based on RECIST v1.1 criteria. To evaluate response duration for the total population. To study whether the patients can use PRO tools during their treatment. To describe hospital admissions To describe patient-reported outcomes according to PRO-CTCAE To describe adverse events according to NCI-CTCAE
Conditions and MedDRA coding
Metastatic non-clear cell renal cell carcinoma
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1.Signed informed consent form must be obtained before any studyrelated procedures start. 2. The patient must be willing and able to follow the protocol. 3. Age ≥ 18 years 4. Histological biopsy-confirmed inoperable, locally advanced or metastatic non-cc RCC or 100% sarcomatoid tumour arising from the kidney found unsuited for surgery with a curative intent. Nephrectomy is not mandatory. a. If the primary disease was diagnosed more than 1 year ago, a new medium needle biopsy must be collected to confirm the diagnosis and tissue must be collected for DNA and RNA analyses. b. If a patient with inoperable relapse had a nephrectomy less than 1 year ago, and no tissue samples are stored in Dansk CancerBiobank, a new medium needle biopsy must be collected for DNA and RNA analyses. c. In cases where metastatic disease was confirmed by biopsy more than 1 year ago without initiated treatment, the patient is offered a new medium needle biopsy, but this is not mandatory for inclusion. d. If the patient had a nephrectomy with tissue stored in Dansk CancerBiobank and has been diagnosed with metastases within 1 year, the patient must be offered a new medium needle biopsy from a metastasis if the metastasis is easily accessible for biopsy, but a new biopsy is not mandatory for inclusion. e. A medium needle biopsy is mainly taken from a metastasis, but biopsy from a renal tumour is allowed. f. A biopsy may not be taken from bones as it cannot be used for molecular analysis. g. If the primary tumour is a proven clear cell RCC, but the biopsy from a metastasis shows non-cc RCC, the patient can be included in the study. 5. Sufficient tissue for DNA analyses, corresponding to 10 slides and RNA analyses corresponding to 1000 tumour cells. 6. Females with a negative pregnancy test or of non-childbearing potential (postmenopausal, hysterectomy or ovariectomy) and nonbreastfeeding. 7. Females of childbearing potential (<2 years after last menstrual period) and males must use effective contraception (pills, intrauterine device, diaphragm or condom with spermicide or sterilisation). 8. Measurable disease (according to RECIST 1.1 criteria) 9. Karnofsky Performance status ≥ 70% / ECOG Performance status 0-2. See Appendix 4. 10. Life expectancy more than 3 months. 11. At baseline, the laboratory values must be: Haematology: Leukocytes ≥ 3.0 x 10E9/L, thrombocytes ≥ 100 x 10E9/L, haemoglobin ≥ 6.2 mmol/l 12. Biochemistry: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), International Normalized Ratio (INR) ≤ 1.5, APTT ≤ 1.5 x ULN, AST, ALT ≤ 2.5 x ULN for patients without liver metastases, ≤ 5 x ULN for patients with liver metastases. eGFR > 30.
Exclusion criteria 1
- 1. Previous systemic treatment for metastatic RCC (including neoadjuvant treatment). 2. Former adjuvant treatment with immune checkpoint inhibitors. 3. Major surgical procedure, open surgical biopsy or significant trauma within 28 days prior to initiation. 4. Serious non-healing wound, ulcer or bone fracture. 5. Auto-immune disease or other condition requiring systemic treatment with either corticosteroids (prednisolone > 10 mg/day or similar) or other immunosuppressive drugs 6. Metastases in the central nervous system (CNS). The patient must have an MRI scan (preferred) or CT scan of the brain (using contrast agent if possible) within 28 prior to initiation. 7. Seizures which cannot be managed with standard medical treatment. 8. If urine dipstick with protein ≥ 3+, urine must be collected over a period of 24 hours which must be < 3.5 grams/day. If degree 2 proteinuria, urine must be collected over a period of 24 hours prior to each prescription. 9. Other malignancy within 5 years (except for curatively treated basal cell carcinoma of the skin and/or cervix carcinoma in situ). 10. Uncontrolled hypertension (≥ 150 mm Hg systolic and/or ≥ 100 mm Hg diastolic) despite maximum antihypertensive medical treatment. 11. Clinically significant (i.e. active) cardiovascular disease, such as cerebrovascular conditions (≤ 6 months), myocardial infarction (≤ 6 months), unstable angina, New York Heart Association (NYHA) congestive heart failure ≥ degree III or serious cardiac arrhythmia requiring medical treatment. Patients with well-managed AFib/AFL may be included. 12. Treatment using other investigational drugs or participation in other studies. 13. Previous or current other diseases, metabolic dysfunction, clinical findings on physical examination or clinical laboratory findings that give suspicion of a disease or condition that would contraindicate the use of an investigational drug or a patient with a high risk of treatment complications. 14. Patients where the investigator finds that patient compliance prevents safe completion of the treatment.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Overall response rate (ORR) + Time-to-treatment failure (TTF)
Secondary endpoints 1
- Progression free survival. Overall survival. Disease control rate. Duration of response. Patient-reported-outcome (PRO) usability. Description of patient-reported-outcome (PRO). Number of hospital admissions. Description of hospital admissions. Description of adverse events.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 15
Tarceva 150 mg film-coated tablets
PRD366727 · Product
- Active substance
- Erlotinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 193500 mg milligram(s)
- Max treatment duration
- 43 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EB02 — -
- Marketing authorisation
- EU/1/05/311/003
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
OPDIVO 10 mg/mL concentrate for solution for infusion.
PRD2941375 · Product
- Active substance
- Nivolumab
- Substance synonyms
- BMS936558, ABP 206
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 480 mg milligram(s)
- Max total dose
- 20160 mg milligram(s)
- Max treatment duration
- 43 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF01 — -
- Marketing authorisation
- EU/1/15/1014/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
CABOMETYX 60 mg film-coated tablets
PRD4382746 · Product
- Active substance
- Cabozantinib
- Substance synonyms
- XL-184, Cyclopropane-1,1-dicarboxylic acid [4-(6,7-dimethoxy-quinolin-4-yloxy)-phenyl]-amide (4-fluoro-phenyl)-amide
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 77400 mg milligram(s)
- Max treatment duration
- 43 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EX07 — -
- Marketing authorisation
- EU/1/16/1136/006
- MA holder
- IPSEN PHARMA
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Kadcyla 160 mg powder for concentrate for solution for infusion.
PRD974895 · Product
- Active substance
- Trastuzumab Emtansine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 3.6 mg/Kg milligram(s)/kilogram
- Max total dose
- 14364 mg milligram(s)
- Max treatment duration
- 43 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FD03 — -
- Marketing authorisation
- EU/1/13/885/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD6503994 · Product
- Active substance
- Palbociclib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 112875 mg milligram(s)
- Max treatment duration
- 43 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EF01 — -
- Marketing authorisation
- EU/1/16/1147/006
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
TAGRISSO 80 mg film-coated tablets
PRD3702398 · Product
- Active substance
- Osimertinib
- Substance synonyms
- AZD9291
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 103200 mg milligram(s)
- Max treatment duration
- 43 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EB04 — -
- Marketing authorisation
- EU/1/16/1086/002
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD4815709 · Product
- Active substance
- Alectinib Hydrochloride
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 1548000 mg milligram(s)
- Max treatment duration
- 43 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01ED03 — -
- Marketing authorisation
- EU/1/16/1169/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
YERVOY 5 mg/ml concentrate for solution for infusion
PRD363755 · Product
- Active substance
- Ipilimumab
- Substance synonyms
- BMS734016, HLX13, IBI310
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 1 mg/kg milligram(s)/kilogram
- Max total dose
- 280 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FX04 — -
- Marketing authorisation
- EU/1/11/698/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD3362141 · Product
- Active substance
- Crizotinib
- Substance synonyms
- PF-02341066
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 645000 mg milligram(s)
- Max treatment duration
- 43 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01ED01 — -
- Marketing authorisation
- EU/1/12/793/003
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lynparza 100 mg film-coated tablets
PRD6163466 · Product
- Active substance
- Olaparib
- Substance synonyms
- AZD-2281, AZD2281
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 1032000 mg milligram(s)
- Max treatment duration
- 43 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XX46 — -
- Marketing authorisation
- EU/1/14/959/003
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323105 · Product
- Active substance
- Pembrolizumab
- Substance synonyms
- Lambrolizumab, MK-3475, SCH-900475, BAT3306, Pabolizumab, FYB206, ABP 234
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 2 mg/Kg milligram(s)/kilogram
- Max total dose
- 4480 mg milligram(s)
- Max treatment duration
- 24 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
- No
- Modified vs. Marketing Authorisation
- No
PRD505800 · Product
- Active substance
- Sunitinib
- Substance synonyms
- SU-011,248, N-(2-(DIETHYLAMINO)ETHYL)-5-((Z)-(5-FLUORO-2-OXO-1,2-DIHYDRO-3H-INDOL-3-YLIDENE)METHYL)-2,4-DIMETHYL-1H-PYRROLE-3-CARBOXAMIDE
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 40600 mg milligram(s)
- Max treatment duration
- 43 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EX01 — -
- Marketing authorisation
- EU/1/06/347/006
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Mekinist 2 mg film-coated tablets
PRD3045799 · Product
- Active substance
- Trametinib
- Substance synonyms
- GSK1120212B
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 2580 mg milligram(s)
- Max treatment duration
- 43 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EE01 — -
- Marketing authorisation
- EU/1/14/931/005
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Imatinib Accord 400 mg film-coated tablets
PRD10150228 · Product
- Active substance
- Imatinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 516000 mg milligram(s)
- Max treatment duration
- 43 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EA01 — -
- Marketing authorisation
- EU/1/13/845/028
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD3045785 · Product
- Active substance
- Dabrafenib
- Substance synonyms
- GSK2118436
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 387000 mg milligram(s)
- Max treatment duration
- 43 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EC02 — -
- Marketing authorisation
- EU/1/13/865/003
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Hovedstaden
- Sponsor organisation
- Region Hovedstaden
- Address
- Borgmester Ib Juuls Vej 1
- City
- Herlev
- Postcode
- 2730
- Country
- Denmark
Scientific contact point
- Organisation
- Region Hovedstaden
- Contact name
- Anne Kirstine Møller Darras
Public contact point
- Organisation
- Region Hovedstaden
- Contact name
- Anne Kirstine Møller Darras
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Denmark | 2020-03-06 | 2024-10-31 | 2025-07-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 18 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-519070-39-00_redacted | 7.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements blank | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DK_redacted | 9 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC alecensa | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC cabometyx | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC ibrance | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC imatinib | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC kadcyla | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC keytruda | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC lynparza | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC mekinist | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC opdivo | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC sutent | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC tafinlar | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC tagrisso | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC tarceva | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC xalkori | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC yervoy | NA |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-16 | Denmark | Acceptable 2024-10-31
|
2024-10-31 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-28 | Denmark | Acceptable 2024-10-31
|
2026-02-28 |