Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333314
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-03-20
Brief Title:
Dostarlimab for Locally Advanced or Metastatic Cancer non-colorectalnon-endometrial with Tumor DMMRMSI
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Dostarlimab As First-line Treatment for Patients with DMMRMSI non-colorectalnon-endometrial Locally Advanced or Metastatic Cancer a Randomized Phase 2 Trial Cohort Pan-MSI ACSE with Crossover in the Standard Arm At Progression
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Pan-MSI-ACSE
Brief Summary:
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 dMMRmicrosatellite 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 dMMRMSI duodenum and small bowel adenocarcinoma gastric and oeso-gastric junction OGJ adenocarcinoma with combined positive score CPS5 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
Adult patients aged 18 years with histologically confirmed dMMRMSI duodenum and small bowel adenocarcinoma gastric and oeso-gastric junction OGJ adenocarcinoma with combined positive score CPS5 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
Detailed Description:
Following signature of the informed consent form patients will enter the pre-inclusion period maximum 28 days prior to start of treatment during which all examinations required to assess their eligibility will be performed including dMMRMSI status demographic data collection tumor evaluation and clinical and laboratory evaluations A centralized confirmation of MMRMSI status by immunohistochemistry IHC or next-generation sequencing NGSpolymerase chain reaction PCR is mandatory to include the patient
Patients will be randomized 11 to receive either dostarlimab intravenously 500 mg every 3 weeks for 4 cycles followed by 1000 mg every 6 weeks for all cycles thereafter experimental arm A or chemotherapy control arm B as per standard of care SOC until disease progression unacceptable toxicity death investigators decision withdrawal of consent or for a maximum of 24 months
Randomization will be stratified by
Primary tumor Duodenum and Small BowelGastricOGJ vs Pancreas Ampulla of Vater vs Other
Age 70 years vs 70 years
Stage Locally advanced vs Metastatic
Patients randomized to Arm B may be eligible to participate in the crossover phase after documentation of disease progression by investigator evaluation according to response evaluation criteria in solid tumors version 11 RECIST v11 Crossover patients may then be treated with dostarlimab for up to 2 years according to the schedule defined for experimental arm A These patients may not initiate treatment with dostarlimab any earlier than 28 days after their last dose of chemotherapy washout period regardless of the time of progression Patients who discontinue dostarlimab treatment after crossover will enter the follow-up phase until the last follow-up visit of the last randomized patient Crossover is optional and is at the discretion of the investigator with coordinating investigators agreement
In both arms tumor evaluation will be done by local investigator at inclusion and post-randomization visits as follow
Treatment period every 6 weeks - 7 days for the first year then every 12 weeks - 7 days for the second year
Follow-up period every 16 weeks - 7 days up to one year after the last follow-up of the last randomized patient
Patients will be randomized 11 to receive either dostarlimab intravenously 500 mg every 3 weeks for 4 cycles followed by 1000 mg every 6 weeks for all cycles thereafter experimental arm A or chemotherapy control arm B as per standard of care SOC until disease progression unacceptable toxicity death investigators decision withdrawal of consent or for a maximum of 24 months
Randomization will be stratified by
Primary tumor Duodenum and Small BowelGastricOGJ vs Pancreas Ampulla of Vater vs Other
Age 70 years vs 70 years
Stage Locally advanced vs Metastatic
Patients randomized to Arm B may be eligible to participate in the crossover phase after documentation of disease progression by investigator evaluation according to response evaluation criteria in solid tumors version 11 RECIST v11 Crossover patients may then be treated with dostarlimab for up to 2 years according to the schedule defined for experimental arm A These patients may not initiate treatment with dostarlimab any earlier than 28 days after their last dose of chemotherapy washout period regardless of the time of progression Patients who discontinue dostarlimab treatment after crossover will enter the follow-up phase until the last follow-up visit of the last randomized patient Crossover is optional and is at the discretion of the investigator with coordinating investigators agreement
In both arms tumor evaluation will be done by local investigator at inclusion and post-randomization visits as follow
Treatment period every 6 weeks - 7 days for the first year then every 12 weeks - 7 days for the second year
Follow-up period every 16 weeks - 7 days up to one year after the last follow-up of the last randomized patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None