Secured Access to Nivolumab for Adult Patients With Selected Rare Cancer Types — AcSé  

Carcinoma, Renal Cell Clinical Trial

Official title: Secured Access to Nivolumab for Adult Patients With Selected Rare Cancer Types

Status Completed

Clinical Trial Summary

This is a Phase 2, non-randomised, open-label, multicentric study to investigate the efficacy and safety of nivolumab 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.

Clinical Trial Description

The study plans to enrol up to 300 patients in total. Eligible patients who have provided their written informed consent for study participation will be assigned to one of 6 cohorts determined by indication:

• Cohort 1: Non-clear cell RCC

• Cohort 2: Rare head and neck cancer

• Cohort 3: Rare skin cancer

• Cohort 4: non-colorectal cancers with microsatellite instability (MSI-nonCRC)

• Cohort 5: Penile cancer

• Cohort 6: POLE exonucleasic domain mutated cancer

Between 20 and 50 patients will be enrolled in each cohort, with the exception of the cohort 1 (Non-clear cell RCC) and cohort 3 (Rare skin cancer). Following the amendment 6, up to a maximum of 20 additional patients may be included in the cohort 1 (Non-clear cell RCC) or cohort 3 (Rare skin cancer), within the limit of 300 patients to be included in total, due to potential signals observed in some subsets.

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. ;

Related Conditions & MeSH terms

• Cancer With POLE Exonucleasic Domain Mutation
• Carcinoma, Renal Cell
• Head and Neck Neoplasm
• Head and Neck Neoplasms
• Microsatellite Instability
• Neoplasms
• Penile Neoplasms
• Skin Neoplasms

• NCT number: NCT03012581
• Study type: Interventional
• Source: UNICANCER
• Status: Completed
• Phase: Phase 2
• Start date: June 16, 2017
• Completion date: November 11, 2023