Last updated on September 2017

Secured Access to Pembrolizumab for Adult Patients With Selected Rare Cancer Types


Brief description of study

This is a Phase 2, non-randomised, open-label, multicentric study to investigate the efficacy and safety of pembrolizumab monotherapy in 6 cohorts of patients with specific rare cancers who have unresectable locally advanced or metastatic disease, which is resistant or refractory to standard therapy, or for which standard therapy does not exist, or is not considered appropriate, and for which no other experimental treatment options are available, in order to identify subsets of patients that may benefit from treatment

Detailed Study Description

The study plans to enrol up to 300 patients in total with between 20 and 50 patients assigned to each cohort according to indication, as follows: - Cohort 1: Rare sarcoma - Cohort 2: Rare ovarian cancer - Cohort 3: Primary central nervous system lymphomas - Cohort 4: Rare thyroid cancer - Cohort 5: Rare malignant neuroendocrine cancer - Cohort 6: Germ-cell cancer The study will use a two-stage Bayesian enrichment design. The first stage treats all patients from the different cohorts with the investigational product and identifies possibly sensitive indications. The second stage will compare outcomes among subsets of patients in the identified cohorts to distinguish between subpopulations of patients who may benefit from the treatment and patients for whom there is no evidence of efficacy.

Clinical Study Identifier: NCT03012620

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Christophe Massard

Gustave Roussy Cancer Campus
Villejuif, France
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