Axitinib and Pembrolizumab in Subjects With Advanced Alveolar Soft Part Sarcoma and Other Soft Ti… (NCT02636725) | Clinical Trial Compass
CompletedPhase 2
Axitinib and Pembrolizumab in Subjects With Advanced Alveolar Soft Part Sarcoma and Other Soft Tissue Sarcomas
United States33 participantsStarted 2016-04-19
Plain-language summary
The purpose of this research study is to test if Axitinib together with Pembrolizumab can slow tumor growth and know the side effects of the combination treatment.
Who can participate
Age range16 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients must have histologically confirmed sarcoma with pathology review required for any outside samples.
✓. The following histologies may be enrolled without prior treatment:
✓. The following histologies may be enrolled only if refractory to anthracycline-based chemotherapy or if the patient refuses to undergo standard of care treatment:
✓. The following histologies may be enrolled only if refractory to at least one line of chemotherapy or if the patient refuses to undergo standard of care treatment:
✓. The following histologies may be enrolled only if refractory to at least first-line targeted therapy or if the patient refuses to undergo standard of care treatment:
✓. Primary tumors of bone including Ewing's sarcoma, osteosarcoma, and dedifferentiated chondrosarcoma may only be enrolled if there are measurable target lesions occurring in soft tissue and they are refractory to standard of care anthracycline-based chemotherapy.
✓. Any other histology or standard of care therapy not specifically addressed will be reviewed by the principal investigator and pathologist for final determination of eligibility.
✓. Measurable disease as defined by RECIST v1.1.
Exclusion criteria
✕. Prior therapy with axitinib. Patients are permitted to have received prior tyrosine kinase inhibitor (TKI) therapy including imatinib, sunitinib, pazopanib, or similar. Patients may have received prior Programmed death 1 (PD-1)/Programmed death-ligand 1 (PD-L1) directed therapy.
What they're measuring
1
Percentage of Evaluable Participants Achieving Progression-Free Survival (PFS) at 3 Months
. Hypersensitivity to axitinib, pembrolizumab or any of its excipients.
✕. Patients may not be receiving any other investigational agents (within 4 weeks prior to Cycle 1, day 1).
✕. Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to Cycle 1, day 1 or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
✕. Patient has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Cycle 1, Day 1 or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
✕. Additional known malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.
✕. Patients with end-organ dysfunction as defined in inclusion criterion (i.e. #11 above).