Actively Recruiting
Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI
Led by UNICANCER · Updated on 2025-12-02
120
Participants Needed
22
Research Sites
318 weeks
Total Duration
On this page
Sponsors
U
UNICANCER
Lead Sponsor
N
National Cancer Institute, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this open-label randomized, multicenter, comparative phase II trial is to evaluate the efficacy of the immunotherapy, dostarlimab, as first-line treatment for deficient mismatch repair (dMMR)/microsatellite instability (MSI) non-resectable metastatic or locally advanced non-colorectal and non-endometrial cancers compared to the standard of care chemotherapy. Adult patients (aged ≥18 years) with histologically confirmed dMMR/MSI duodenum and small bowel adenocarcinoma, gastric and oeso-gastric junction (OGJ) adenocarcinoma with combined positive score (CPS)\<5, pancreatic adenocarcinoma, ampulla of vater adenocarcinoma, adrenocortical carcinoma, carcinoma of unknown primary site, neuroendocrine carcinoma (Grade3) all primary, and soft tissue sarcoma (except Gastro-Intestinal Stromal Tumor) will be included in this study. They will be randomized and treated with either dostarlimab (experimental arm A), or chemotherapy (control arm B). Patients with documented disease progression following the first line chemotherapy (Arm B) may be eligible for crossover to be treated with dostarlimab, with the same schedule as arm A.
CONDITIONS
Official Title
Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must have signed a written informed consent form.
- Age 18 years or older.
- Locally advanced or metastatic disease with no previous systemic anti-cancer treatment in these settings and not suitable for complete surgical resection.
- Histologically confirmed dMMR/MSI-H solid tumors excluding colorectal or endometrial cancers, including duodenum and small bowel adenocarcinoma, gastric and oeso-gastric junction adenocarcinoma with CPS<5, pancreatic adenocarcinoma, ampulla of Vater adenocarcinoma, adrenocortical carcinoma, carcinoma of unknown primary site, neuroendocrine carcinoma (Grade 3), and soft tissue sarcoma except Gastro-Intestinal Stromal Tumor.
- If received adjuvant therapy for non-metastatic disease, it must have been completed more than 6 months before metastatic or recurrent diagnosis.
- Availability of tumor tissue or slides for centralized confirmation of MMR/MSI status.
- Central confirmation of dMMR/MSI status by review committee before inclusion.
- At least one measurable lesion within 28 days before treatment start.
- Eastern Cooperative Oncology Group Performance status (ECOG PS) 0-1.
- Adequate blood counts: ANC ≥1.5 x 10⁹/L; platelets ≥100 x 10⁹/L; hemoglobin ≥9 g/dL.
- Adequate kidney function: serum creatinine <120 µM or clearance >50 ml/min.
- Adequate liver function: bilirubin ≤1.5 x ULN; ALT and AST ≤3 x ULN (≤5 x ULN if liver metastases).
- Coagulation parameters within specified limits; stable warfarin dose allowed.
- Women of childbearing potential must have negative pregnancy test within 72 hours before randomization.
- Men and women of childbearing potential must agree to use contraception during and after study treatment.
- Registered in a National Health Care System.
- Willing and able to comply with study requirements.
You will not qualify if you...
- Colorectal and endometrial cancers or primary tumors not listed in inclusion.
- Previous treatment with anti-PD-1, PD-L1, or CTLA-4 antibodies or immunotherapy.
- Use of investigational drugs within 4 weeks (6 weeks for monoclonal antibodies) before study.
- Prior systemic anti-cancer or radiation therapy for the cancer under study.
- Active autoimmune disease requiring systemic treatment in past 2 years or history of interstitial lung disease.
- Uncontrolled brain metastases or other serious concurrent illnesses or infections.
- HER2-positive gastric carcinoma.
- Serious uncontrolled non-malignant diseases or poor medical risk.
- Prior allogeneic bone marrow or solid organ transplantation.
- Recent systemic corticosteroids or immunosuppressive drugs use within 2 weeks before treatment.
- Other cancers except adequately treated in-situ cervical carcinoma, basal or squamous cell skin cancer, or cancer in remission >2 years.
- Known HIV infection.
- Recent live vaccine within 14 days.
- Active hepatitis B or C infection unless resolved.
- Severe hypersensitivity to investigational products.
- Pregnant or breastfeeding women.
- Participation in another clinical trial within 30 days before study treatment.
- Conditions that may interfere with study compliance.
- Persons deprived of liberty or under protective custody or guardianship.
AI-Screening
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Trial Site Locations
Total: 22 locations
1
Institut de Cancérologie de l'Ouest
Angers, France
Not Yet Recruiting
2
Institut du Cancer Avignon-Provence
Avignon, France
Not Yet Recruiting
3
CHU Jean Minjoz
Besançon, France
Not Yet Recruiting
4
CHU Morvan
Brest, France
Not Yet Recruiting
5
Centre François Baclesse
Caen, France
Not Yet Recruiting
6
Centre Jean Perrin
Clermont-Ferrand, France
Not Yet Recruiting
7
CHU - Henri Mondor
Créteil, France
Not Yet Recruiting
8
Centre Georges François Leclerc
Dijon, France
Not Yet Recruiting
9
Centre Léon Bérard
Lyon, France
Actively Recruiting
10
Hôpital la Timone
Marseille, France
Not Yet Recruiting
11
Institut Paoli Calmettes
Marseille, France
Not Yet Recruiting
12
Institut de Cancérologie de Lorraine
Nancy, France
Not Yet Recruiting
13
Institut Mutualiste Montsouris
Paris, France
Not Yet Recruiting
14
CHU de Bordeaux - Hôpital Haut -Lèvêque
Pessac, France
Not Yet Recruiting
15
CHU de Poitiers
Poitiers, France
Not Yet Recruiting
16
Institut Jean Godinot
Reims, France
Not Yet Recruiting
17
Centre Eugène Marquis
Rennes, France
Not Yet Recruiting
18
CHU de Rouen
Rouen, France
Not Yet Recruiting
19
Institut de Cancérologie de l'Ouest
Saint-Herblain, France
Not Yet Recruiting
20
CHU de Toulouse Hôpital Rangueil
Toulouse, France
Not Yet Recruiting
21
Gustave Roussy Grand Paris
Villejuif, France
Not Yet Recruiting
22
Hôpital Saint-Antoine
Paris, Île-de-France Region, France
Not Yet Recruiting
Research Team
A
Assia LAMRANI-GHAOUTI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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