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New treatment option for Pancreatic Adenocarcinoma
Official title Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI
ClinicalTrials.gov ID: NCT06333314
What this study is testing
What is Dostarlimab?
Dostarlimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pancreatic adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient must have signed a written informed consent form prior any trial specific procedures. -
- 18 years or older patients.
- Documented locally advanced or metastatic disease with no previous systemic anti-cancer treatment in these settings and not suitable for complete...
- Histologically proven, dMMR/MSI-H solid tumors that are not colorectal or endometrial cancers and including one of the following: duodenum and small...
- If patient received adjuvant therapy for non-metastatic disease, this therapy should be completed more than 6 months before the diagnosis of...
You likely can't join if
- Colorectal and endometrial cancer and all primary tumor not listed in inclusion criterion #4.
- Previous exposure to anti-PD-1 or PD-L1 or anti-CTL-4 antibodies or treatment with immunotherapy.
- Previous exposure to any investigational drug within 4 weeks (6 weeks for monoclonal antibodies) before the first dose in the study.
- Previous exposure to any systemic anti-cancer therapy or radiation therapy for the cancer for which the patient is being enrolled.
- Active autoimmune disease: Active autoimmune disease requiring systemic treatment in the past 2 years (excluding replacement therapy) or any history...
- Uncontrolled central nervous system metastases or carcinomatous meningitis or other concurrent illness or ongoing or active infections.
See the full eligibility criteria
Who can join
- Patient must have signed a written informed consent form prior any trial specific procedures. -
- 18 years or older patients.
- Documented locally advanced or metastatic disease with no previous systemic anti-cancer treatment in these settings and not suitable for complete surgical resection.
- Histologically proven, dMMR/MSI-H solid tumors that are not colorectal or endometrial cancers and including one of the following: duodenum and small bowel adenocarcinoma, gastric and oeso-gastric junction adenocarcinoma...
- If patient received adjuvant therapy for non-metastatic disease, this therapy should be completed more than 6 months before the diagnosis of metastatic or recurrent disease.
- Availability of minimum 1 block of tumor tissue or 20 slides (archival (\<2 years) or fresh biopsy specimen of primary and or metastasis) for centralized confirmation of MMR/MSI status by IHC or NGS/PCR, and for...
- Patients with dMMR/MSI tumor analyzed by IHC, PCR (for Gastric and OGJ adenocarcinoma, and duodenum and small bowel adenocarcinoma only), and/or NGS at the recruiting center should be confirmed by central review within...
- Presence of at least one measurable lesion within 28 days before the start of treatment according to RECIST v1.1.
- Eastern Cooperative Oncology Group Performance status (ECOG PS) 0-1.
- Haematological status: absolute neutrophil count (ANC) ≥1.5 x 10⁹/L; platelets ≥100 x 10⁹/L; haemoglobin ≥9 g/dL.
- Adequate renal function: serum creatinine level \ 50 ml/min (Modification of the Diet in Renal Disease [MDRD] or Cockcroft and Gault).
- Adequate liver function: serum bilirubin ≤1.5 x upper normal limit (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x ULN, unless liver metastases are present, in which case they must be ≤...
- For patients not taking warfarin: International normalised ratio (INR) \<1.5 or prothrombin time (PT) \<1.5 x ULN and either partial thromboplastin time (PTT) or activated PTT (aPTT) \<1.5 x ULN. Participants taking...
- Women of childbearing potential must have a negative serum pregnancy test performed within 72 hours before the date of randomization.
- Men, and women of childbearing potential must agree to use adequate contraception for the duration of trial participation and for 4 months after the last dose of dostarlimab (used in first line or at crossover) or for...
- Registration in a National Health Care System.
- Patient is willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study.
What rules you out
- Colorectal and endometrial cancer and all primary tumor not listed in inclusion criterion #4.
- Previous exposure to anti-PD-1 or PD-L1 or anti-CTL-4 antibodies or treatment with immunotherapy.
- Previous exposure to any investigational drug within 4 weeks (6 weeks for monoclonal antibodies) before the first dose in the study.
- Previous exposure to any systemic anti-cancer therapy or radiation therapy for the cancer for which the patient is being enrolled.
- Active autoimmune disease: Active autoimmune disease requiring systemic treatment in the past 2 years (excluding replacement therapy) or any history of interstitial lung disease (patients with ancient auto-immune...
- Uncontrolled central nervous system metastases or carcinomatous meningitis or other concurrent illness or ongoing or active infections.
- Patients with HER2-positive gastric carcinoma.
- Other serious and uncontrolled non-malignant disease or is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active infection requiring systemic therapy...
- Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
- Has received treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide...
- Other concomitant or previous malignancy other than the disease under study, except as noted below: i. adequately treated in-situ carcinoma of the uterine cervix, ii. basal or squamous cell carcinoma of the skin, iii...
- Known Human Immunodeficiency Virus (HIV) infection.
- Received live vaccine within 14 days.
- Patient has documented presence of HBsAg [or HBcAb] at pre-inclusion visit or within 3 months prior to first dose of study intervention. Participant has a positive hepatitis C virus (HCV) antibody test result at...
- Known prior severe hypersensitivity to investigational product or any component in its formulation.
- Pregnant or breast feeding women.
- Participation in another clinical trial within 30 days prior to the first study treatment administration or concomitantly with the trial.
- Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Person deprived of their liberty or under protective custody or guardianship. Patient assigned by chance to receive SOC (Arm B) may crossover to receive dostarlimab (Arm A) in case of documented progressive disease...
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Avignon, France
- Besançon, France
- Brest, France
- Caen, France
- Clermont-Ferrand, France
- Créteil, France
- Dijon, France
- Lyon, France
- Marseille, France
- Nancy, France
- Paris, France
- Pessac, France
- Poitiers, France
- Reims, France
- Rennes, France
- Rouen, France
- Saint-Herblain, France
- Toulouse, France
- Villejuif, France
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Avignon, France; Besançon, France; Brest, France; Caen, France; Clermont-Ferrand, France and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.