Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
419
Countries
2
Sites
9
Advanced Hepatobiliary Cancer
1. To assess the efficacy of novel immunomodulators alone or in combination with other anticancer drugs in participants with specified advanced solid tumors by evaluation of ORR (Objective Response Rate) for sub-study 1 HCC and PFS (Progression-free Survival) for sub-study 2 BTC 2. To assess safety and tolerability of …
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 12 Jul 2023 → ongoing
- Decision date (initial)
- 2023-05-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AstraZeneca AB
External identifiers
- EU CT number
- 2022-502317-29-00
- ClinicalTrials.gov
- NCT05775159
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Pharmacogenetic, Safety, Therapy, Pharmacodynamic, Efficacy
1. To assess the efficacy of novel immunomodulators alone or in combination with other anticancer drugs in participants with specified advanced solid tumors by evaluation of ORR (Objective Response Rate) for sub-study 1 HCC and PFS (Progression-free Survival) for sub-study 2 BTC
2. To assess safety and tolerability of novel immunomodulators alone or in combination with other anticancer drugs in participants with specified advanced solid tumors.
Secondary objectives 3
- To further assess the efficacy of novel immunomodulators alone or incombination with other anticancer drugs in participants with specified advanced solid tumors by evaluation of DoR, DCR at 12 and 24 weeks, PFS, and OS.
- To assess PK of novel immunomodulators alone or in combination with other anticancer drugs in participants with specified advanced solid tumors.
- To evaluate the immunogenicity of novel immunomodulators alone or in combination with other anticancer drugs in participants with specified advanced solid tumors.
Conditions and MedDRA coding
Advanced Hepatobiliary Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10017614 | Gallbladder cancer | 100000004864 |
| 20.0 | PT | 10073071 | Hepatocellular carcinoma | 100000004864 |
| 20.0 | PT | 10008593 | Cholangiocarcinoma | 100000004864 |
| 20.0 | LLT | 10004598 | Bile duct carcinoma | 10029104 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screen period, treatment Period and Follow-up Period Screen period: Day -28 to Day -1
Treatment Period: 21 days/ cycle until disease progression or unacceptable toxicity develops.
Follow-up Period: including End of Treatment visit, 30-day follow-up, 90-day follow up, and progression/survival follow up visit.
|
2 | None | Cohort1A: Cohort 1A: volrustomig monotherapy Cohort 1B: Cohort 1B: volrustomig + bevacizumab Cohort 1C: Cohort 1C: volrustomig + lenvatinib Cohort 2A: Cohort 2A: rilvegostomig + gemcitabine + cisplatin Cohort 2B: Cohort 2B: volrustomig + gemcitabine + cisplatin Cohort 1D: Cohort 1D: (Rilve+Beva)/Volru as maintainance treatment Cohort 1E: Cohort 1E: rilvegostomig + bevacizumab |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Age ≥18 years at the time of signing the ICF.
- Provision of a signed and dated written ICF.
- Confirmed locally advanced or metastatic solid tumor specified in substudy based on histopathology.
- Adequate organ and bone marrow function.
- At least 1 measurable not previously irradiated lesion per RECIST 1.1
- Life expectancy of at least 12 weeks at the time of screening.
- Willing and able to provide an adequate tumor sample.
Exclusion criteria 9
- HCC only: History of allogeneic organ transplantation or in the waiting-list of allogeneic organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders.
- Uncontrolled intercurrent illness.
- History of another primary malignancy, leptomeningeal carcinomatosis, and active primary immunodeficiency.
- Active infection, brain metastases or spinal cord compression.
- HCC only: History of hepatic encephalopathy within 12 months prior to treatment allocation.
- Previous treatment in the present study.
- Participants co-infected with HBV and hepatitis D virus (HDV)
- BTC only: History of allogeneic organ transplantation.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- ORR for sub-study 1 and PFS for sub-study 2 determined by the Investigator at local site per RECIST 1.1.
- Incidence of AEs, AESIs, SAEs, and AEs leading to discontinuation of treatment
Secondary endpoints 6
- Duration Of Response (DOR) per RECIST 1.1 based on Investigator assessment
- Disease Control Rate (DCR) at 12 and 24 weeks per RECIST 1.1 as assessed by the Investigator
- Progression free survival (PFS) per RECIST 1.1 based on Investigator assessment
- Overall Survival (OS)
- Serum concentrations of novel immunomodulators and derived PK parameters
- Incidences of ADAs against novel immunomodulators in serum
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD2958373 · Product
- Active substance
- Lenvatinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 12 mg milligram(s)
- Max total dose
- 4380 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XE29 — -
- Marketing authorisation
- EU/1/15/1002/001
- MA holder
- EISAI GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Avastin 25 mg/ml concentrate for solution for infusion
PRD2153901 · Product
- Active substance
- Bevacizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 2250 mg milligram(s)
- Max total dose
- 40500 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FG01 — -
- Marketing authorisation
- EU/1/04/300/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10191166 · Product
- Active substance
- Volrustomig
- Substance synonyms
- MEDI5752, Human IgG1 monoclonal antibody with an engineered Fc domain targeting PD-1 and CTLA-4
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
PRD10448215 · Product
- Active substance
- Rilvegostomig
- Substance synonyms
- AZD 2936, Bispecific IgG1 monoclonal antibody against PDCD1 and TIGIT
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 750 mg milligram(s)
- Max total dose
- 13500 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 10
Gemcitabin HEXAL® 40 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD783842 · Product
- Active substance
- Gemcitabine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1000 mg/m2 milligram(s)/square meter
- Max total dose
- 00 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC05 — GEMCITABINE
- Marketing authorisation
- 80317.00.00
- MA holder
- HEXAL AG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Gemcitabina Accord 100 mg/ml concentrato per soluzione per infusione.
PRD3332925 · Product
- Active substance
- Gemcitabine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1000 mg/m2 milligram(s)/square meter
- Max total dose
- 00 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC05 — GEMCITABINE
- Marketing authorisation
- 040928044
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Gemcitabina Accord 100 mg/ml concentrato per soluzione per infusione.
PRD3332927 · Product
- Active substance
- Gemcitabine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1000 mg/m2 milligram(s)/square meter
- Max total dose
- 00 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC05 — GEMCITABINE
- Marketing authorisation
- 040928020
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Gemsol 40 mg/ml concentrato per soluzione per infusione
PRD774187 · Product
- Active substance
- Gemcitabine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1000 mg/m2 milligram(s)/square meter
- Max total dose
- 00 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC05 — GEMCITABINE
- Marketing authorisation
- 040278020
- MA holder
- SANDOZ S.P.A.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cisplatino Accord Healthcare Italia 1 mg/ml concentrato per soluzione per infusione
PRD3327491 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 25 mg/m2 milligram(s)/square meter
- Max total dose
- 00 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 040210039
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cisplatino Sandoz 0,5 mg/ml – Concentrato per soluzione per infusione
PRD10787621 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 25 mg/m2 milligram(s)/square meter
- Max total dose
- 00 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 033346038
- MA holder
- SANDOZ S.P.A.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cisplatino Accord Healthcare Italia 1 mg/ml concentrato per soluzione per infusione
PRD3327490 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 25 mg/m2 milligram(s)/square meter
- Max total dose
- 00 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 040210041
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung
PRD759858 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 25 mg/m2 milligram(s)/square meter
- Max total dose
- 00 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 39021.01.00
- MA holder
- HEXAL AG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Mycophenolate Mofetil 500 mg film-coated tablets
PRD1597921 · Product
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2000 mg milligram(s)
- Max total dose
- 730000 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA06 — MYCOPHENOLIC ACID
- Marketing authorisation
- PL 20117/0065
- MA holder
- MORNINGSIDE HEALTHCARE LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Remsima 120 mg solution for injection in pre-filled pen
PRD7752789 · Product
- Active substance
- Infliximab
- Substance synonyms
- ABP 710, CT-P13, NI-071, PF-06438179
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 5 mg/kg milligram(s)/kilogram
- Max total dose
- 2250 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AB02 — -
- Marketing authorisation
- EU/1/13/853/014
- MA holder
- CELLTRION HEALTHCARE HUNGARY KFT
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- Clinical Trial Information Center
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- Clinical Trial Information Center
Locations
2 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruitment ended | 30 | 4 |
| Spain | Ongoing, recruitment ended | 30 | 5 |
| Rest of world
United States, Taiwan, Japan, China, Korea, Republic of, Hong Kong, United Kingdom
|
— | 359 | — |
Investigational sites
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Abdominal Medical Oncology, Via Mariano Semmola 52, 80131, Naples
Ospedale San Raffaele S.r.l.
Medical Oncology, Via Olgettina 60, 20132, Milan
Humanitas Research Hospital
Medical Oncology and Hematology, Via Alessandro Manzoni 56, 20089, Rozzano
Careggi University Hospital
Oncologia Medica e Clinica, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Hospital General Universitario Gregorio Maranon
Digestive, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Clinic De Barcelona
Digestive, Calle Rosellon 138, 08036, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitari Vall D Hebron
Digestive, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
University Clinic Of Navarra
Digestive, Pio XII Etorbidea 36, 31008, Pamplona
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 |
|---|---|---|---|---|---|
| Italy | 2023-07-24 | 2023-09-28 | 2026-05-01 | ||
| Spain | 2023-07-12 | 2023-07-13 | 2026-05-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 38 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2022-502317-29-00_redacted | 6.0 |
| Protocol (for publication) | D1_Sub-Protocol_1_HCC_2022-502317-29-00_redacted | 5.0 |
| Protocol (for publication) | D1_Sub-Protocol_2_BTC_2022-502317-29-00_redacted | 5.0 |
| Protocol (for publication) | REDUNDANT-D5-Protocol Substudy2-redacted | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adults Retreatment | v3.0es |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Genetic Subject | v3.0es |
| Subject information and informed consent form (for publication) | L1_SIS and ICF BTC Adults IIes_redacted | V2es |
| Subject information and informed consent form (for publication) | L1_SIS and ICF BTC Adults VIIIes_redacted | 8es |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for adult BTC_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for adult HCC_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for adult HCC_V3_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for DP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for DP_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Optional Genetic Research | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Optional Research | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Optional Research_redacted | 12.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Pregnant Partners | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Retreatment | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF HCC Adults IIIes_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF HCC Adults IXes_redacted | 9es |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner IIIesII | v3.0es2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_clean | 5.0es |
| Subject information and informed consent form (for publication) | REDUNDANT_L1_SIS and ICF for adult BTC_redacted | 2.0 |
| Subject information and informed consent form (for publication) | REDUNDANT_L1_SIS and ICF for adult HCC_redacted | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Lenvatinib | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC_Bevacizumab | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | Reference Safety Information for non-AZ IMP_nRSI_Bevacizumab | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | Reference Safety Information for non-AZ IMP_nRSI_Lenvatinib | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis BTC_IT_2022-502317-29-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis HCC_IT_2022-502317-29-00_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_Lay language_2022-502317-29-00_redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_Lay language_2022-502317-29-00_redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_2022-502317-29-00_redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_Lay language_2022-502317-29-00_redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_tmg_azd2936 | 5.0 |
| Synopsis of the protocol (for publication) | D1_TMGs_Volrustomig_redacted | 5.0 |
Application history
13 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-10 | Spain | Acceptable 2023-05-29
|
2023-05-29 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-06-02 | Acceptable 2023-05-29
|
2023-06-02 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-06-16 | Spain | Acceptable 2023-08-21
|
2023-08-23 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-10-19 | Spain | Acceptable 2023-11-27
|
2023-11-27 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-02-12 | Spain | Acceptable 2024-04-01
|
2024-04-23 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-06-17 | Spain | Acceptable 2024-08-21
|
2024-08-21 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-10-23 | Spain | Acceptable 2024-12-02
|
2024-12-02 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-01-21 | Spain | Acceptable 2025-03-05
|
2025-03-07 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-05-13 | Acceptable 2025-03-05
|
2025-05-13 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-07-28 | Spain | Acceptable 2025-09-24
|
2025-09-25 |
| 11 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-10-30 | Spain | Acceptable 2025-12-09
|
2025-12-10 |
| 12 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-02-13 | Spain | Acceptable 2026-04-13
|
2026-04-15 |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-05-06 | Acceptable 2026-04-13
|
2026-05-06 |