A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Duarte, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04623775
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Relatlimab — BIOLOGICAL
    Specified dose on specified days
  • Carboplatin — DRUG
    Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
  • Cisplatin — DRUG
    Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
  • Paclitaxel — DRUG
    Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
  • Nab-Paclitaxel — DRUG
    Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
  • Pemetrexed — DRUG
    Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.

Study Details

The purpose of this study is to assess the safety profile of relatlimab plus nivolumab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves overall response rate (ORR) when compared to nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small cell lung cancer (NSCLC).

Key Dates

Start date
Feb 17, 2021
Status verified
Oct 2025
Primary completion
Jan 11, 2024
Completion
Feb 27, 2026

Study Design

Enrollment
468 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))
  • Experimental: Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))
  • Experimental: Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)
  • Active Comparator: Part 2: Arm D (Nivolumab + PDCT)

Primary Outcome Measure

TRAEs Leading to Discontinuation Within 12 Weeks of First Dose in Part 1 [ Time Frame: from first dose to 12 weeks after first dose ]

Locations (29)

FacilityCityStateZIPSite coordinators
Local Institution - 0160DuarteCalifornia91010-
Local Institution - 0081OrangeCalifornia92868-
Local Institution - 0139New HavenConnecticut06520-
Local Institution - 0153JacksonvilleFlorida32204-
Local Institution - 0011Port Saint LucieFlorida34952-
Local Institution - 0089AthensGeorgia30607-
Local Institution - 0121WichitaKansas67214-
Local Institution - 0159LexingtonKentucky40503-
Local Institution - 0002LouisvilleKentucky40241-
Local Institution - 0082ScarboroughMaine04074-
Local Institution - 0129OmahaNebraska68130-
Local Institution - 0152Howell TownshipNew Jersey07731-
Local Institution - 0124Johnson CityNew York13790-
Local Institution - 0162MineolaNew York11501-
Local Institution - 0128New YorkNew York10016-
Local Institution - 0165New YorkNew York10021-
Local Institution - 0097The BronxNew York10461-
Local Institution - 0117DurhamNorth Carolina27710-
Local Institution - 0156CincinnatiOhio45219-
Local Institution - 0155ClevelandOhio44109-
Local Institution - 0084LancasterPennsylvania17604-
Local Institution - 0147PittsburghPennsylvania15212-
Local Institution - 0148ProvidenceRhode Island02903-
Local Institution - 0083GreenvilleSouth Carolina29607-
Local Institution - 0149DallasTexas75390-9179-
Local Institution - 0091HarlingenTexas78550-
Local Institution - 0001TylerTexas75701-
Local Institution - 0092SpokaneWashington99208-
Local Institution - 0157MorgantownWest Virginia26506-

Related coverage on Hipa.ai

Find similar trials in Duarte, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Local Institution - 0160· Duarte, CALocal Institution - 0081· Orange, CALocal Institution - 0139· New Haven, CTLocal Institution - 0153· Jacksonville, FLLocal Institution - 0011· Port Saint Lucie, FLLocal Institution - 0089· Athens, GA

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