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 range
18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Response rate (ORR) (Cohort 3)
Timeframe: Until objective tumor response, on average 10 months
. 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.
. 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.