Regorafenib With Tislelizumab in Patients With Selected Mismatch Repair-Proficient/Microsatellite… (NCT05582031) | Clinical Trial Compass
WithdrawnPhase 2
Regorafenib With Tislelizumab in Patients With Selected Mismatch Repair-Proficient/Microsatellite Stable Cancers
Stopped: Study never started/ will not proceed.
0Started 2023-04-30
Plain-language summary
REFIT-MSS is a non-randomized, multicenter, open-label, multi-cohort, 2-stage, phase II trial to evaluate the efficacy and safety of regorafenib in combination with tislelizumab (referred as Rego-Tisle) in adult patients with select advance, previously treated, Mismatch Repair-Proficient/Microsatellite (pMMR/MSS) stable solid cancers.
The multi-cohort design will allow for the examination of 8 separate cohorts of different cancers to determine whether further examination may be warranted in the individual indications.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed and dated PICF obtained prior to any trial-specific procedure that is not part of standard patient care.
✓. Patient is ≥ 18 years-old at the time of PICF signature (or the legal age of consent in the jurisdiction in which the trial is taking place).
✓. Histologically or cytologically confirmed solid tumor belonging to one of the cohorts specified in the protocol. To be eligible, patient must meet the criteria for tumor type, stage and prior anti-cancer therapy according to the protocol.
✓. Tumor must be:
✓. Measurable disease by CT or MRI per Response Evaluation Criteria in Solid Tumors (version 1.1), based on tumor assessment performed within 28 days of enrollment.
✓. Progressive cancer at the time of trial entry based on clinical or radiographic findings or tumor marker evaluation, according to Investigator's judgment, or cancer that is not amenable to standard therapies even if not progressing.
✓. ECOG Performance Scale score of 0 or 1 at enrollment.
✓. Adequate hematologic and organ function as assessed by the following laboratory tests, performed at screening (specified within the protocol).
Exclusion criteria
✕. Prior treatment with regorafenib.
✕. Prior treatment with a PD1, PD-L1/PD-L2, or CTLA-4 inhibitor, or any other drug or antibody targeting T-cell co-stimulation or checkpoint pathways, except in patients that meet all the following criteria:
What they're measuring
1
Progression Free Survival at 6 months (PFS-6) as per Investigator Assessment
✕. Neoadjuvant and/or adjuvant setting and had no relapse within 12 months of completing immunotherapy
✕. Advanced disease setting and had no progression during immunotherapy
✕. Evidence of progressive or symptomatic CNS metastases. Patients with treated CNS metastases are eligible if they meet all the following criteria:
✕. Previous treatment with live vaccine within 28 days of planned start of trial drugs (seasonal flu vaccines that do not contain a live virus are permitted).
✕. Concurrent participation in another clinical study, unless it is: (a) an observational (noninterventional) study, or (b) the follow-up period of an interventional trial and patient did not receive an investigational agent/device within 28 days before enrollment (or within 5 half-lives of the drug).
✕. Major surgical procedure, open biopsy, significant traumatic injury, radiation therapy and/or systemic anti-cancer therapy ≤28 days prior to enrollment. Patients must have recovered adequately from the toxicity and/or complications from these interventions before enrollment. Radiation therapy given with palliative intent is allowable if finalized ≥ 14 days prior to enrollment.