Trial Of Pembrolizumab And Nintedanib (NCT02856425) | Clinical Trial Compass
CompletedPhase 1
Trial Of Pembrolizumab And Nintedanib
France196 participantsStarted 2016-11-10
Plain-language summary
Both anti-angiogenesis and anti PD1 immunotherapy have shown beneficial efficacy in solid tumors and in particular in NSCLC. Therefore it is of interest to investigate whether the combination of these two approaches is tolerable. Moreover, comprehensive pre-clinical and clinical rationale sustain the hypothesis that anti-VEGF could synergize with immunotherapy for the benefit of the patients.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18
✓. Patients with advanced/metastatic cancer who have progressed after at least one line of standard therapy or are intolerant to standard therapy. Patients must fit into one of the following groups:
✓. ECOG performance status of score 0 or 1
✓. Adequate organ function as defined by the following criteria :
✓. At least one measurable lesion according to RECIST v1.1 (Appendix 4) criteria and modified RECIST for mesothelioma only (Appendix 6) or any other baseline prerequisite for the assessment of the principal judgment criteria.
✓. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days prior to initiation of treatment. Both sexually active females and males (and their female partners) patients must agree to use two methods of effective contraception, one of them being a barrier method, or to abstain from sexual activity during the study and for at least 4 months after last study drug administration.
✓. Signed and dated written informed consent prior to admission to the study
✓. Patient affiliated to a social security regimen or beneficiary of the same
Exclusion criteria
✕. Prior treatment with nintedanib
✕. Known hypersensitivity to trial drugs or their excipients, peanut or soya or to contrast media
✕
What they're measuring
1
MTD of Nintedanib
Timeframe: Assessed within 24 months after study start
. Prior treatment with pembrolizumab or any other anti PD1 or anti-PDL1 agents
✕. Concurrent steroid medication (except topical or aerosol steroids). Any steroid medication should have been stopped for more than 7 days prior beginning of therapy.
✕. Chemo-, hormono-, radio- (except for brain and extremities) or immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks or 5 half-life times (whatever the shortest) prior to treatment with the trial drugs.
✕. Administration of a live, attenuated vaccine within 4 weeks before registration
✕. Treatment with systemic immunosuppressive medications (including but not limited to steroids azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 2 weeks prior to registration