^
5d
Trial completion date
|
Opdivo (nivolumab) • relatlimab (BMS-986016)
11d
CA209-906: Nivolumab +/- Relatlimab Prior to Chemoradiation With II/III Gastro/Esophageal Cancer (clinicaltrials.gov)
P1, N=32, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Aug 2025 --> Aug 2027 | Trial primary completion date: Mar 2025 --> Mar 2027
Trial completion date • Trial primary completion date
|
Opdivo (nivolumab) • carboplatin • paclitaxel • relatlimab (BMS-986016)
18d
Effect of prior and first-line immunotherapy on baseline immune biomarkers and modulation of the tumor microenvironment in response to nivolumab and relatlimab combination therapy in patients with melanoma from RELATIVITY-020. (PubMed, J Immunother Cancer)
Nivolumab and relatlimab combination therapy can modulate the tumor microenvironment in patients with both IO-refractory and IO-naïve melanoma. Further research is needed to identify patients who will most benefit from anti-LAG-3/PD-(L)1 agents, and to elucidate the mechanisms of action of, and resistance to, this combination therapy in patients with advanced melanoma.
Journal • PD(L)-1 Biomarker • IO biomarker
|
CD8 (cluster of differentiation 8)
|
PD-L1 expression
|
Opdivo (nivolumab) • relatlimab (BMS-986016)
19d
The Risk of Adrenal Insufficiency after Treatment with Relatlimab in Combination with Nivolumab is Higher than Expected. (PubMed, J Clin Endocrinol Metab)
This study is the first cohort analysis of hypophysitis in patients treated with relatlimab-nivolumab compared to nivolumab monotherapy. Combination treatment with relatlimab-nivolumab confers a significantly higher risk of developing adrenal insufficiency, likely secondary to hypophysitis, compared to nivolumab alone.
Journal
|
LAG3 (Lymphocyte Activating 3)
|
Opdivo (nivolumab) • relatlimab (BMS-986016)
27d
Safety Study of BMS-986016 With or Without Nivolumab in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=35, Completed, Bristol-Myers Squibb | Active, not recruiting --> Completed | Trial completion date: Jul 2025 --> Jul 2024
Trial completion • Trial completion date
|
Opdivo (nivolumab) • relatlimab (BMS-986016)
29d
Immuno-Oncology Drugs Elotuzumab, Anti-LAG-3 and Anti-TIGIT (clinicaltrials.gov)
P1/2, N=14, Terminated, Multiple Myeloma Research Consortium | Trial completion date: Dec 2024 --> Aug 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2023 --> Aug 2024; Pharmaceutical support has been discontinued.
Trial completion date • Trial termination • Trial primary completion date
|
dexamethasone • pomalidomide • Empliciti (elotuzumab) • relatlimab (BMS-986016) • renvistobart (BMS-986207)
1m
RELATIVITY-106: A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer (clinicaltrials.gov)
P1/2, N=162, Active, not recruiting, Bristol-Myers Squibb | Recruiting --> Active, not recruiting
Enrollment closed
|
Opdivo (nivolumab) • Avastin (bevacizumab) • relatlimab (BMS-986016)
1m
New P2 trial
|
MGMT (6-O-methylguanine-DNA methyltransferase)
|
Opdivo (nivolumab) • relatlimab (BMS-986016)
1m
Tri-specific tribodies targeting 5T4, CD3, and immune checkpoint drive stronger functional T-cell responses than combinations of antibody therapeutics. (PubMed, Cell Death Discov)
We found that the novel tri-specific tribodies activated human peripheral blood mononuclear cells more efficiently than clinically validated mAbs (atezolizumab, pembrolizumab, and relatlimab) either used alone or in combination with 53 P, leading to a stronger tumor cytotoxicity and cytokines release. We shed light on the molecular basis of this potentiated anti-tumor activity by evidencing that the insertion of the anti-PD-L1 moiety in 53L10 led not only to stronger binding of the tri-specific to tumor cells but also efficiently blocked the effects of increased PD-L1 on tumor cells, induced by IFNγ secretion also due to T-cell activation. These results are important also for the design of novel T-cell engagers targeting other tumor antigens.
Journal
|
PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • LAG3 (Lymphocyte Activating 3)
|
Keytruda (pembrolizumab) • Tecentriq (atezolizumab) • relatlimab (BMS-986016)
2ms
Study of Nivolumab and Relatlimab in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer (clinicaltrials.gov)
P2, N=59, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Active, not recruiting --> Completed | Trial completion date: Feb 2025 --> Sep 2024
Trial completion • Trial completion date
|
PD-L1 (Programmed death ligand 1)
|
Opdivo (nivolumab) • relatlimab (BMS-986016)
2ms
Enrollment open
|
Keytruda (pembrolizumab) • Yervoy (ipilimumab) • carboplatin • temozolomide • albumin-bound paclitaxel • cyclophosphamide • dacarbazine • Opdualag (nivolumab/relatlimab-rmbw) • Amtagvi (lifileucel) • relatlimab (BMS-986016) • IMA203
2ms
Journal
|
LAG3 (Lymphocyte Activating 3)
|
Opdivo (nivolumab) • relatlimab (BMS-986016)
2ms
Nivolumab combination therapies in patients with advanced gastric and gastroesophageal junction cancer: the phase II FRACTION gastric cancer study. (PubMed, ESMO Open)
While ORR did not meet prespecified expansion criteria in any treatment arm, the safety profile of the combinations was manageable. FRACTION-GC represents a novel adaptive protocol for testing multiple combination immunotherapies.
P2 data • Journal
|
LAG3 (Lymphocyte Activating 3) • IDO1 (Indoleamine 2,3-dioxygenase 1)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • linrodostat (BMS-986205) • relatlimab (BMS-986016)
2ms
CA224-1065: Neoadjuvant Nivolumab and Relatlimab in Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov)
P2, N=20, Recruiting, Melanoma Institute Australia | Not yet recruiting --> Recruiting
Enrollment open
|
Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
3ms
An update on access to novel treatment for metastatic melanoma in Europe - A 2024 survey of the European melanoma registry and the European association of dermato-oncology. (PubMed, Eur J Cancer)
The nivolumab/relatlimab combination is licensed only for PDL-1-negative melanoma and reimbursed in seven countries of Europe. Tebentafusp is reimbursed in 15 countries and talimogene laherpervec in 5. In 2024, adjuvant treatments for stage III melanoma are reimbursed in 22 countries for dabrafenib/trametinib and 24 of 27 for anti-PD1 antibodies. Pembrolizumab and nivolumab are reimbursed in 15 and 8 countries, respectively, for stage IIB/IIC disease.While there have been improvements in the reimbursement of metastatic melanoma treatments in Europe, challenges and discrepancies remain. Further efforts at European and global levels are needed to harmonize and enhance access to cancer medicines.
Journal
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 negative
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Mekinist (trametinib) • Tafinlar (dabrafenib) • Kimmtrak (tebentafusp-tebn) • relatlimab (BMS-986016)
3ms
Trial completion date • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Opdivo (nivolumab) • cisplatin • carboplatin • albumin-bound paclitaxel • pemetrexed • relatlimab (BMS-986016)
3ms
Trial completion date • Metastases • Immuno-oncology
|
Opdivo (nivolumab) • relatlimab (BMS-986016)
3ms
New P3 trial • Metastases
|
Keytruda (pembrolizumab) • Yervoy (ipilimumab) • carboplatin • temozolomide • albumin-bound paclitaxel • cyclophosphamide • dacarbazine • Opdualag (nivolumab/relatlimab-rmbw) • Amtagvi (lifileucel) • relatlimab (BMS-986016) • IMA203
3ms
Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma (clinicaltrials.gov)
P2, N=90, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Mar 2027 --> Jul 2027 | Trial primary completion date: Mar 2027 --> Jul 2027
Trial completion date • Trial primary completion date • IO biomarker • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Yervoy (ipilimumab) • Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
3ms
CA224-056: Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer (clinicaltrials.gov)
P2, N=80, Recruiting, Dan Zandberg | Trial completion date: Sep 2027 --> Sep 2026 | Trial primary completion date: May 2027 --> May 2026
Trial completion date • Trial primary completion date • Combination therapy • Tumor mutational burden • IO biomarker
|
TMB (Tumor Mutational Burden) • LAG3 (Lymphocyte Activating 3)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • relatlimab (BMS-986016)
3ms
REACTION (Radiation Enhanced Assessment of Combination Therapies in Immuno-ONcology) - Nivolumab or Nivolumab in Combination With Other Immuno-oncology (IO) Agents After Targeted Systemic Radiation in Patients With Advanced Esophagogastric Cancer (clinicaltrials.gov)
P1/2, N=21, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Apr 2025 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
Trial completion date • Trial primary completion date • Combination therapy • Metastases • Immuno-oncology
|
Opdivo (nivolumab) • relatlimab (BMS-986016)
3ms
IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301) (clinicaltrials.gov)
P3, N=680, Recruiting, Immunocore Ltd | Trial primary completion date: Dec 2026 --> Oct 2027
Trial primary completion date • Metastases
|
BRAF (B-raf proto-oncogene) • HLA-A (Major Histocompatibility Complex, Class I, A)
|
BRAF mutation • BRAF V600 • HLA-A*02
|
Opdualag (nivolumab/relatlimab-rmbw) • brenetafusp (IMC-F106C) • relatlimab (BMS-986016)
3ms
Nivolumab plus relatlimab and nivolumab plus ipilimumab for patients with advanced renal cell carcinoma: results from the open-label, randomised, phase II FRACTION-RCC trial. (PubMed, ESMO Open)
Results showed antitumour activity and manageable safety with NIVO + RELA. Findings also support NIVO + IPI as an effective combination regimen in IO-naive patients with aRCC.
P2 data • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
|
PD-L1 (Programmed death ligand 1) • LAG3 (Lymphocyte Activating 3) • RELA (RELA Proto-Oncogene)
|
PD-L1 expression
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • relatlimab (BMS-986016)
3ms
CA209-1451: Neoadjuvant Opdualag Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma (clinicaltrials.gov)
P2, N=30, Not yet recruiting, University of California, San Diego | Initiation date: Oct 2024 --> Jan 2025
Trial initiation date
|
Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
3ms
CA224-094: Nivolumab Plus Relatlimab in Patients With Metastatic Uveal Melanoma (clinicaltrials.gov)
P2, N=27, Active, not recruiting, Jose Lutzky, MD | Trial completion date: Dec 2026 --> Jan 2026 | Trial primary completion date: Dec 2024 --> Jan 2024
Trial completion date • Trial primary completion date • Metastases
|
LAG3 (Lymphocyte Activating 3) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
Opdivo (nivolumab) • relatlimab (BMS-986016)
4ms
Trial completion • Combination therapy • Metastases
|
MSI (Microsatellite instability)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • Cotellic (cobimetinib) • Darzalex (daratumumab) • relatlimab (BMS-986016)
4ms
Immune Checkpoint Inhibitor Myopathy: The Double-Edged Sword of Cancer Immunotherapy. (PubMed, Neurology)
These monoclonal antibodies target immune checkpoints, including cytotoxic T-lymphocyte-associated protein 4 (ipilimumab and tremelimumab), programmed death 1 (nivolumab, pembrolizumab, cemiplimab, and dostarlimab), programmed death ligand 1 (atezolizumab, avelumab, and durvalumab), and lymphocyte activation gene 3 (relatlimab), and effectively augment the immune response against tumor cells. Despite clinical improvements with immunomodulatory therapy, with corticosteroids the mainstay of treatment, mortality remains high, particularly in those with associated myocarditis or respiratory failure requiring intubation, where mortality occurs in up to 50%. ICI withdrawal can lead to cancer progression and death, highlighting a need for improved approaches to ICI rechallenge, performed in limited patients with variable success to date.
Review • Journal • Checkpoint inhibition
|
PD-L1 (Programmed death ligand 1) • IL6 (Interleukin 6) • LAG3 (Lymphocyte Activating 3) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Yervoy (ipilimumab) • Imfinzi (durvalumab) • Bavencio (avelumab) • Imjudo (tremelimumab-actl) • Jemperli (dostarlimab-gxly) • Libtayo (cemiplimab-rwlc) • relatlimab (BMS-986016)
4ms
RELATIVITY-106: A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer (clinicaltrials.gov)
P1/2, N=162, Recruiting, Bristol-Myers Squibb | Trial primary completion date: Jun 2024 --> Oct 2025
Trial primary completion date • Combination therapy • Metastases
|
Opdivo (nivolumab) • Avastin (bevacizumab) • relatlimab (BMS-986016)
4ms
Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma (clinicaltrials.gov)
P2, N=90, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Phase classification: P1 --> P2
Phase classification
|
PD-L1 (Programmed death ligand 1)
|
Yervoy (ipilimumab) • Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
4ms
New P1/2 trial
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • relatlimab (BMS-986016)
4ms
Enrollment open • Checkpoint inhibition • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
5ms
A Trial of LNS8801 with or Without Pembrolizumab in Patients with Refractory Melanoma (clinicaltrials.gov)
P2/3, N=135, Not yet recruiting, Linnaeus Therapeutics, Inc. | Phase classification: P3 --> P2/3
Phase classification
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab) • temozolomide • dacarbazine • relatlimab (BMS-986016) • LNS8801
5ms
A comprehensive review of immune checkpoint inhibitors for cancer treatment. (PubMed, Int Immunopharmacol)
Immune checkpoint inhibitors (ICIs) have shown great success, with FDA-approved drugs like PD-1 inhibitors (Nivolumab, Pembrolizumab, Cemiplimab), PD-L1 inhibitors (Atezolizumab, Durvalumab, Avelumab), and CTLA-4 inhibitors (Ipilimumab, Tremelimumab), alongside LAG-3 inhibitor Relatlimab. This review aims to fill this gap by providing an analysis of the current clinical status of ICIs, emerging biomarkers, mechanisms of resistance, strategies to enhance therapeutic efficacy, and assessment of adverse effects. This review is crucial to furthering our understanding of ICIs and optimizing their application in cancer therapy.
Review • Journal • Checkpoint inhibition • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
|
TMB (Tumor Mutational Burden) • IFNG (Interferon, gamma) • LAG3 (Lymphocyte Activating 3) • CD276 (CD276 Molecule) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • BTLA (B And T Lymphocyte Associated)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Yervoy (ipilimumab) • Imfinzi (durvalumab) • Bavencio (avelumab) • Imjudo (tremelimumab-actl) • Libtayo (cemiplimab-rwlc) • relatlimab (BMS-986016)
5ms
Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor (clinicaltrials.gov)
P2, N=42, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Oct 2024 --> Oct 2025 | Trial primary completion date: Oct 2024 --> Oct 2025
Trial completion date • Trial primary completion date • Mismatch repair • Metastases
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
Opdivo (nivolumab) • relatlimab (BMS-986016)
5ms
Deciphering LAG-3: unveiling molecular mechanisms and clinical advancements. (PubMed, Biomark Res)
Currently, with the approval of relatlimab, a LAG-3 blocking antibody, a third player, has been used in the fight against cancer...However, the complex biology of LAG-3 may hinder its full development as a therapeutic alternative. In this review, we provide in-depth insight into the biology of LAG-3 and its current and future development in cancer treatment.
Review • Journal
|
LAG3 (Lymphocyte Activating 3) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
favezelimab (MK-4280) • fianlimab (REGN3767) • relatlimab (BMS-986016)
5ms
Phase II Trial of Immunotherapy in Patients with Carcinomas Arising from the Renal Medulla (clinicaltrials.gov)
P2, N=30, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting
Enrollment closed
|
SMARCB1 (SWI/SNF Related, Matrix Associated, Actin Dependent Regulator Of Chromatin, Subfamily B, Member 1)
|
SMARCB1 negative
|
Opdivo (nivolumab) • relatlimab (BMS-986016)
5ms
New P2 trial
|
Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
5ms
Effect of LNS8801 (with or Without Pembrolizumab) on Melanoma (clinicaltrials.gov)
P3, N=135, Not yet recruiting, Linnaeus Therapeutics, Inc.
New P3 trial
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab) • temozolomide • dacarbazine • relatlimab (BMS-986016) • LNS8801
6ms
Nivolumab, BMS-936558 in Combination with Relatlimab, BMS-986016 in Patients with Metastatic Melanoma Naïve to Prior Immunotherapy in the Metastatic Setting (clinicaltrials.gov)
P2, N=42, Completed, John Kirkwood | Active, not recruiting --> Completed | Trial completion date: Jul 2027 --> Jul 2024 | Trial primary completion date: Jul 2027 --> Jul 2024
Trial completion • Trial completion date • Trial primary completion date • Combination therapy • IO biomarker • Metastases
|
PD-1 (Programmed cell death 1) • LAG3 (Lymphocyte Activating 3)
|
PD-1 expression • LAG3 expression
|
Opdivo (nivolumab) • relatlimab (BMS-986016)
6ms
Real-world treatment patterns and outcomes of patients with advanced melanoma treated with nivolumab plus relatlimab. (PubMed, Oncologist)
Our retrospective review at a tertiary cancer center of patients with stage 3 and 4 melanoma treated with NIVO-RELA revealed an overall response rate (ORR) of 39%, with notable improvements in median PFS and ORR, especially in first-line treated patients. Our study highlights the superior efficacy of NIVO-RELA over previous reports, demonstrating its significant potential in the treatment landscape of advanced melanoma.
Journal • HEOR • Real-world evidence • Real-world • Metastases
|
LAG3 (Lymphocyte Activating 3) • RELA (RELA Proto-Oncogene)
|
Opdivo (nivolumab) • relatlimab (BMS-986016)
6ms
Nivolumab for the Treatment of Patients With Metastatic Urothelial Cancer With ARID1A Mutation and Stratify Response Based on CXCL13 Expression (clinicaltrials.gov)
P2, N=30, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2026
Trial completion date • Trial primary completion date • Metastases
|
ARID1A (AT-rich interaction domain 1A) • CXCL13 (Chemokine (C-X-C motif) ligand 13)
|
ARID1A mutation • CXCL13 expression
|
Opdivo (nivolumab) • relatlimab (BMS-986016)
6ms
CA209-906: Nivolumab +/- Relatlimab Prior to Chemoradiation With II/III Gastro/Esophageal Cancer (clinicaltrials.gov)
P1, N=32, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Feb 2025 --> Aug 2025 | Trial primary completion date: Sep 2024 --> Mar 2025
Trial completion date • Trial primary completion date
|
Opdivo (nivolumab) • carboplatin • paclitaxel • relatlimab (BMS-986016)