A Safety and Efficacy Study of CC-90011 in Combination With Nivolumab in Subjects With Advanced Cancers

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Celgene
Study ID
NCT04350463
Phase
PHASE2
Status
Completed

Conditions

  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CC-90011 — DRUG
    CC-90011
  • Nivolumab — DRUG
    Nivolumab

Study Details

This is a Phase 2, multicenter, open-label, multi-cohort study to assess safety and efficacy of CC-90011 in combination with nivolumab in subjects with small cell lung cancer or squamous non-small cell lung cancer who have progressed after 1 or 2 lines of therapies. The primary objectives of the study are to evaluate the overall response rate of subjects treated with CC-90011 in combination with nivolumab in three cohorts: * Cohort A: SCLC in ICI naïve subjects * Cohort B: SCLC in ICI progressor subjects * Cohort C: sqNSCLC in ICI progressor subjects Overall response rate is defined as the proportion of subjects in the treated population who had complete response (CR) or partial response (PR) as assessed by Investigator review per RECIST v1.1. In Cohort A, expected ORR for nivolumab monotherapy is 14% while target ORR is 30%. To achieve at least 80% power with one-sided type 1 error 0.1, 39 subjects will be enrolled according to a 2-stage group sequential design based on a binomial test. In stage 1, 12 subjects will be enrolled and treated with CC-90011 in combination with nivolumab. If there are 2 or more subjects responding, Cohort A will continue to enroll an additional 27 subjects. If 1 or less subjects respond in stage 1, Cohort A will stop for futility. In Cohort B and C, expected ORR for nivolumab monotherapy is 5% while target ORR is 15%. To achieve at least 80% power with one-sided type 1 error 0.1, 48 subjects will be enrolled according to a 2-stage group sequential design based on a binomial test. In stage 1, 14 subjects will be enrolled and treated with CC-90011 in combination with nivolumab. If there are 1 or more subjects responding, Cohort B and C will continue to enroll an additional 34 subjects each. If 0 subjects respond in stage 1, Cohort B and C will stop for futility.

Key Dates

Start date
Jul 14, 2020
Status verified
Jan 2025
Primary completion
Dec 19, 2023
Completion
Dec 19, 2023

Study Design

Enrollment
92 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: SCLC in ICI naïve subjects
    CC-90011 will be given orally (PO) at a dose of 40 mg on a once weekly basis in a continuous 28-day cycle. Nivolumab will be administered intravenously at a dose of 480 mg every 4 weeks per local practice as a 30 minute or a 60-minute infusion as per local practice.
  • Experimental: Cohort B: SCLC in ICI progressor subjects
    CC-90011 will be given orally (PO) at a dose of 40 mg on a once weekly basis in a continuous 28-day cycle. Nivolumab will be administered intravenously at a dose of 480 mg every 4 weeks per local practice as a 30 minute or a 60-minute infusion as per local practice.
  • Experimental: Cohort C: sqNSCLC in ICI progressor subjects
    CC-90011 will be given orally (PO) at a dose of 40 mg on a once weekly basis in a continuous 28-day cycle. Nivolumab will be administered intravenously at a dose of 480 mg every 4 weeks per local practice as a 30 minute or a 60-minute infusion as per local practice.

Primary Outcome Measure

Overall Response Rate [ Time Frame: Every 6 weeks post Cycle 1 (each cycle is of 28 days) Day 1 for the first 24 weeks and then every 8 weeks until disease progression, new anticancer therapy, death or withdrawal by participants (up to approximately 33 months) ]

Locations (8)

FacilityCityStateZIPSite coordinators
Local Institution - 102IndianapolisIndiana46260-
Local Institution - 106New YorkNew York10021-
Local Institution - 105CantonOhio44718-
Local Institution - 104ClevelandOhio44106-
Local Institution - 109PittsburghPennsylvania15232-
Local Institution - 107Fort Sam HoustonTexas78235-8200-
Local Institution - 110HoustonTexas77090-
Local Institution - 111FairfaxVirginia22031-

Find similar trials in Indianapolis, IN

By research site
Local Institution - 102· Indianapolis, INLocal Institution - 106· New York, NYLocal Institution - 105· Canton, OHLocal Institution - 104· Cleveland, OHLocal Institution - 109· Pittsburgh, PALocal Institution - 107· Fort Sam Houston, TX

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