Pembrolizumab in Treating Patients With Rare Tumors That Cannot Be Removed by Surgery or Are Meta… (NCT02721732) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Pembrolizumab in Treating Patients With Rare Tumors That Cannot Be Removed by Surgery or Are Metastatic
United States157 participantsStarted 2016-08-15
Plain-language summary
This phase II trial studies how well pembrolizumab works in treating patients with rare tumors that cannot be removed by surgery or have spread to other parts of the body. Monoclonal antibodies, such as pembrolizumab, may block specific proteins found on white blood cells which may strengthen the immune system and control tumor growth.
Who can participate
Age range18 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:
* Be willing and able to provide written informed consent/assent for the trial
* Have measurable disease based on RECIST 1.1 or irRECIST; only cohort 9 and 10 can have evaluable disease (non-measurable lesions); tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions; patients may have bone metastatic disease evaluable according to tumor evaluation criteria best suitable and accepted for the tumor type evaluated
* Have one of the following advanced (unresectable and/or metastatic) solid tumor indications that has progressed following standard therapies, where standard therapies are available:
* Squamous cell carcinoma of the skin
* Small cell malignancies of non-pulmonary origin
* Adrenocortical carcinoma
* Medullary renal cell carcinoma
* Carcinoma of unknown primary
* Penile carcinoma
* Vascular sarcoma
* Germ cell tumor
* Paraganglioma-pheochromocytoma
* Other rare tumors (except those tumor types listed in exclusion)
* Have failed prior treatment within 6 months of consent date
* Have biopsiable disease; subjects must have at least one lesion amenable to biopsy; tumor lesions used for biopsy should not be lesions used as target lesions; in cohort 9: paraganglioma-pheochromocytoma or cohort 10, where there is prominent bony disease, biopsies may not be possible due to the nature of the disease
* Be willing to provide archival tissue; if archival tissue is…
What they're measuring
1
Non-progression Rate (NPR) at 27 Weeks by irRECIST