Actively Recruiting
IMMUNORARE5: National Phase II Trials of Domvanalimab and Zimberelimab Immunotherapy in Patients with Advanced Rare Cancers
Led by Hospices Civils de Lyon · Updated on 2025-10-06
154
Participants Needed
15
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination of immunotherapy drugs, Domvanalimab and Zimberelimab, in patients with advanced rare cancers who have not responded to at least one prior standard treatment. The study focuses on five specific types of rare cancers: peritoneal mesothelioma, gestational trophoblastic tumors, B3 thymomas and thymic carcinomas, anaplastic thyroid carcinomas, and gastroenteropancreatic neuroendocrine tumors including carcinoid tumors. This phase II trial aims to address the lack of effective treatment options for these cancers by testing this new immunotherapy approach. Patients will receive Domvanalimab and Zimberelimab via intravenous infusions. For most cancer types, these drugs are given every three weeks at fixed doses. For patients with gastroenteropancreatic neuroendocrine tumors and carcinoid tumors, the treatment includes higher doses of these drugs administered every four weeks combined with an induction chemotherapy regimen called FOLFOX-4 given every two weeks for four months. Treatment continues until disease progression, unacceptable side effects, death, or up to two years if complete response is achieved. Following treatment, patients are monitored for at least one year. Participants will undergo regular evaluations including imaging scans and blood tests to measure tumor response, progression-free survival, and overall survival. The study also tracks safety by monitoring adverse events during and up to five months after treatment ends. Researchers aim to assess how well the immunotherapy combination controls the cancer at 24 weeks and its overall tolerability. The total study duration allows for long-term follow-up to better understand treatment benefits and risks.
CONDITIONS
Brief Title
IMMUNORARE5: A National Platform of 5 Academic Phase II Trials Coordinated by Lyon University Hospital to Assess the Safety and the Efficacy of the IMMUNOtherapy With Domvanalimab + Zimberelimab Combination in Patients With Advanced RARE Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Histologically confirmed advanced solid tumors of one of the specified rare cancer types
- Disease progression or resistance after at least one line of standard systemic treatment
- No curative surgery option at inclusion (with exceptions for cohort 1)
- Measurable or assessable disease by imaging or biological markers
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Willingness to provide tumor tissue sample or undergo biopsy if safe
- Adequate bone marrow, kidney, and liver function within 28 days before treatment
- Life expectancy of at least 16 weeks
- Use of highly effective contraception for men and women of childbearing age
- Signed informed consent
- Affiliation to French social security or equivalent
- Ability to comply with study protocol and follow-up visits
- Specific cohort criteria for each cancer type as detailed in the protocol
You will not qualify if you...
- Prior treatment with immune checkpoint inhibitors or other immunotherapies
- Active or history of significant autoimmune or immune-related disorders, with some exceptions
- Requirement for chronic systemic steroids or immunosuppressive medications
- Uncontrolled illnesses that could interfere with study or increase risk
- Second primary cancer except certain treated and stable cancers
- Meningeal involvement or untreated/symptomatic CNS metastases
- Recent systemic chemotherapy or radiotherapy within specified timeframes
- Use of other investigational agents that may interfere with study outcomes
- Gastrointestinal conditions preventing oral medication absorption
- Active infections with HIV, HBV, or HCV
- Prior organ transplantation including allogeneic stem cell transplant
- Participation in another clinical trial that may interfere
- Under legal guardianship or tutorship
- Specific exclusions per cohort such as planned surgery, certain tumor types, or contraindications to chemotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year on average
Participants receive intravenous Domvanalimab and Zimberelimab every 3 or 4 weeks, with some receiving additional FOLFOX-4 chemotherapy every 2 weeks for 4 months as induction treatment.
Every 2 to 4 weeks depending on treatment regimen
Duration - Up to 5 months after treatment ends, with long-term survival follow-up up to nearly 7 years
Participants are monitored for safety and survival outcomes after treatment ends.
Visits during follow-up period as scheduled for safety assessments
Trial Site Locations
Total: 15 locations
1
Institut de Cancerologie de l'Ouest , medical oncology department
Angers, France, 49055
Not Yet Recruiting
2
Institut Bergonié, medical oncology department
Bordeaux, France, 33076
Not Yet Recruiting
3
Hospices Civils de Lyon, Thoracic Oncology Department, Louis Pradel Hospital
Bron, France, 69500
Actively Recruiting
4
Centre Hospitalier Universitaire de Lille, medical oncology department
Lille, France, 59037
Not Yet Recruiting
5
Hospices Civils de Lyon, Medical Oncology Department, Edouard Herriot Hospital
Lyon, France, 69003
Actively Recruiting
6
AP-HM, TIMONE Hospital, medical oncology department
Marseille, France, 13009
Not Yet Recruiting
7
Institut Paoli-Calmettes Marseille, medical oncology department
Marseille, France, 13009
Not Yet Recruiting
8
Institut Régional du Cancer de Montpellier, medical oncology department
Montpellier, France, 34298
Not Yet Recruiting
9
Institut Curie, thoracic oncology department
Paris, France, 75005
Not Yet Recruiting
10
AP-HP, Tenon Hospital, medical oncology department
Paris, France, 75020
Not Yet Recruiting
11
Hospices Civils de Lyon, Medical Oncology Department, Lyon SUD Hospital
Pierre-Bénite, France, 69310
Actively Recruiting
12
Centre Eugène Marquis, medical oncology department
Rennes, France, 35042
Not Yet Recruiting
13
Insitut de Cancérologie Strasbourg Europe, medical oncology department
Strasbourg, France, 67200
Not Yet Recruiting
14
ONCOPOLE Claudius Regaud, IUCT-Oncopole, medical oncology department
Toulouse, France, 31059
Not Yet Recruiting
15
Institut Gustave Roussy, medical oncology department
Villejuif, France, 94805
Not Yet Recruiting
Research Team
B
Benoit YOU, Prof; MD/PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
5
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