NCT03743766

Nivolumab, BMS-936558 in Combination with Relatlimab, BMS-986016 in Patients with Metastatic Melanoma Naïve to Prior Immunotherapy in the Metastatic Setting

Completed Phase 2 Last updated 25 September 2024

What this trial tests

Phase 2 trial testing Relatlimab in Melanoma in 42 participants. Completed in 3 July 2024.

Timeline

29 March 2019

Primary endpoint
3 July 2024

3 July 2024

Quick facts

Lead sponsor	John Kirkwood
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	29 March 2019
Primary completion	3 July 2024
Estimated completion	3 July 2024
Sites	1 location across United States

Drugs / interventions tested

• Relatlimab — full drug profile →
• Nivolumab (nivolumab) — full drug profile →
• Relatlimab + Nivolumab

Conditions studied

• Melanoma — all drugs for Melanoma →

Sponsor

John Kirkwood — full company profile →

Who can join

18 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main goal of this study is to evaluate the antitumor activity of relatlimab and nivolumab in combination in subjects with unresectable or metastatic melanoma who have not received prior treatment with immunotherapy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Novel immune checkpoint targets: moving beyond PD-1 and CTLA-4.
   Qin S, Xu L, Yi M, Yu S, et al · · 2019 · cited 909× · PMID 31690319 · DOI 10.1186/s12943-019-1091-2
2. Regulatory T cells in tumor microenvironment: new mechanisms, potential therapeutic strategies and future prospects.
   Li C, Jiang P, Wei S, Xu X, et al · · 2020 · cited 679× · PMID 32680511 · DOI 10.1186/s12943-020-01234-1
3. Applications of single-cell sequencing in cancer research: progress and perspectives.
   Lei Y, Tang R, Xu J, Wang W, et al · · 2021 · cited 428× · PMID 34108022 · DOI 10.1186/s13045-021-01105-2
4. NK Cell-Based Immune Checkpoint Inhibition.
   Khan M, Arooj S, Wang H. · · 2020 · cited 296× · PMID 32117298 · DOI 10.3389/fimmu.2020.00167
5. Development of Immunotherapy Combination Strategies in Cancer.
   Yap TA, Parkes EE, Peng W, Moyers JT, et al · · 2021 · cited 260× · PMID 33811048 · DOI 10.1158/2159-8290.cd-20-1209
6. LAG-3 and PD-1 synergize on CD8<sup>+</sup> T cells to drive T cell exhaustion and hinder autocrine IFN-γ-dependent anti-tumor immunity.
   Andrews LP, Butler SC, Cui J, Cillo AR, et al · · 2024 · cited 190× · PMID 39121848 · DOI 10.1016/j.cell.2024.07.016
7. Immune checkpoint modulators in cancer immunotherapy: recent advances and emerging concepts.
   Wang Y, Zhang H, Liu C, Wang Z, et al · · 2022 · cited 179× · PMID 35978433 · DOI 10.1186/s13045-022-01325-0
8. Understanding LAG-3 Signaling.
   Chocarro L, Blanco E, Zuazo M, Arasanz H, et al · · 2021 · cited 154× · PMID 34067904 · DOI 10.3390/ijms22105282