Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients with PD1-high… (NCT04802876) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients with PD1-high MRNA Expressing Tumors
Spain184 participantsStarted 2021-04-12
Plain-language summary
This is an open-label, parallel group, non-randomized, multicenter phase II study to evaluate the efficacy of spartalizumab (cohorts 1 and 2) and tislelizumab (cohort 3) in monotherapy in patients with PD1-high-expressing tumors.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of PD1 mRNA high-expression (cohort 1, 3) or PD1 mRNA low-expression (cohort 2) determined on the tumor sample will be enrolled in this study. Enrollment of patients \> 75 years of age is allowed after consultation and approval of the study medical monitor.
✓. Life expectancy \> 3 months as per investigator opinion.
✓. The participant (or legally acceptable representative if applicable) provides written specific informed consent for the remaining screening tests and study procedures before inclusion in the trial.
✓. Have measurable disease based on RECIST 1.1 or RANO criteria, as appropriate to tumor type. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
✓. Have radiologic evidence of disease progression or recurrence after the previous oncologic treatment
✓. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 10 days prior to the date of allocation.
✓. Have adequate organ function. Specimens must be collected within 28 days prior to the start of study treatment.
✓. Patients could have received a maximum of 3 lines of prior standard of care chemotherapy in the inoperable/metastatic setting.
Exclusion criteria
✕. A Women of childbearing potential who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
What they're measuring
1
Overall Response rate (ORR) (Cohort 3)
Timeframe: Until objective tumor response, on average 10 months
✕. Has received prior therapy with an anti-PD1, anti-PDL1, or anti-PDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.
✕. Has received prior systemic anti-cancer therapy, including investigational agents within 2 weeks. Medical Monitor could consider shorter interval for kinase inhibitors or other short half-life drugs prior to allocation.
✕. Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
✕. Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment.
✕. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 2 weeks prior to the first dose of study treatment.
✕. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
✕. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.