NCT03012581

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 269 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Nivolumab	Treatment

Timeline

• Start date: 2017-06-16
• Primary completion: 2022-12-22
• Completion: 2023-11-11
• First posted: 2017-01-06
• Last updated: 2024-02-28

Locations

1 site across 1 country: France