- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Opdivo (nivolumab) / Ono Pharma, BMS
P1 data, Clinical Trial,Phase I, Journal, PD(L)-1 Biomarker, IO biomarker, Circulating tumor DNA: Neoadjuvant nivolumab or nivolumab plus LAG-3 inhibitor relatlimab in resectable esophageal/gastroesophageal junction cancer: a phase Ib trial and ctDNA analyses. (Pubmed Central) - Apr 22, 2024
P1
Our findings provide insights into the safety profile of combined PD-1 and LAG-3 blockade in gastroesophageal cancer and highlight the potential of ctDNA analysis to dynamically assess systemic tumor burden during neoadjuvant ICI that may open a therapeutic window for future intervention. ClinicalTrials.gov registration: NCT03044613 .
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Opdivo (nivolumab) / Ono Pharma, BMS
Trial completion date, Trial primary completion date, Checkpoint inhibition, Metastases: Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors (clinicaltrials.gov) - Apr 22, 2024
P1, N=33, Not yet recruiting,
ClinicalTrials.gov registration: NCT03044613 . Trial completion date: Mar 2030 --> Jun 2030 | Trial primary completion date: Jun 2028 --> Sep 2028
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Opdualag (nivolumab/relatlimab) / BMS, Ono Pharma
Journal, Metastases: Pseudoprogression in a patient with metastatic melanoma treated with PD-1 and LAG-3 inhibition. (Pubmed Central) - Apr 19, 2024
The patient experienced a radiographic increase in liver metastatic lesion size, but was found to have a subsequent reduction in these lesions. The patient has been on therapy for 18 months without evidence of disease progression and continues to be clinically well-appearing.
- |||||||||| relatlimab (BMS-986016) / BMS, Opdivo (nivolumab) / BMS
Trial completion, Trial completion date, Trial primary completion date, Tumor mutational burden, Metastases: NCI-2018-01517: Nivolumab and Relatlimab in Treating Participants With Advanced Chordoma (clinicaltrials.gov) - Apr 16, 2024
P2, N=10, Completed,
The patient has been on therapy for 18 months without evidence of disease progression and continues to be clinically well-appearing. Active, not recruiting --> Completed | Trial completion date: Apr 2025 --> Sep 2023 | Trial primary completion date: Apr 2024 --> Sep 2023
- |||||||||| Review, Journal, PD(L)-1 Biomarker, IO biomarker, Metastases: The treatment of Advanced Melanoma: Current approaches and new challenges. (Pubmed Central) - Apr 8, 2024
However, the introduction of new ICIs, like relatlimab, has added complexity to first-line therapy decisions...We also provide the latest insights into the treatment of rare melanoma subtypes, such as uveal melanoma, where tebentafusp has shown promising improvements in overall survival for metastatic uveal melanoma patients. This review provides invaluable insights for clinicians, enabling informed treatment choices and deepening our understanding of the multifaceted challenges associated with advanced melanoma management.
- |||||||||| Remicade (infliximab) / J&J, Renflexis (infliximab-abda) / Yuhan Corp, Biogen, Ewopharma, Samsung, Organon
Trial completion date, Trial primary completion date, Adverse events, Combination therapy, Metastases: PD-1 Antibody Therapy + Infliximab for Metastatic Melanoma (clinicaltrials.gov) - Mar 21, 2024
P2, N=36, Recruiting,
Trial completion date: Nov 2027 --> Mar 2027 | Trial primary completion date: Nov 2024 --> Mar 2026 Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Jun 2023 --> Jun 2025
- |||||||||| relatlimab (BMS-986016) / BMS, Opdivo (nivolumab) / BMS
Biomarker, Enrollment closed, Enrollment change, Trial primary completion date, Combination therapy, Metastases: Study of Nivolumab and Relatlimab in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer (clinicaltrials.gov) - Mar 18, 2024
P2, N=59, Active, not recruiting,
Recruiting --> Active, not recruiting | N=24 --> 1 Recruiting --> Active, not recruiting | N=96 --> 59 | Trial primary completion date: Feb 2025 --> May 2024
- |||||||||| relatlimab (BMS-986016) / BMS, Opdivo (nivolumab) / BMS
Trial completion date, Combination therapy, IO biomarker, Metastases, Immuno-oncology: RELATIVITY-073: A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncology Therapy After Prior Treatment With Tyrosine Kinase Inhibitors (clinicaltrials.gov) - Mar 15, 2024
P2, N=266, Active, not recruiting,
Phase classification: P2/3 --> P3 Trial completion date: Jan 2025 --> Sep 2024
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Opdivo (nivolumab) / Ono Pharma, BMS
Cost-Effectiveness Analysis of Nivolumab Plus Relatlimab (NIVO+RELA) Versus Current Standard of Care (SOC) for Patients with Unresectable or Metastatic Melanoma in Canada () - Mar 8, 2024 - Abstract #ISPOR2024ISPOR_399;
OBJECTIVES: To evaluate the cost-effectiveness of fixed-dose combination NIVO+RELA versus SOC for unresectable or metastatic melanoma (including immunotherapies [IOs]: NIVO, pembrolizumab [PEMBRO], nivolumab+ipilimumab [NIVO+IPI], IPI, and BRAF/MEK inhibitors: vemurafenib+cobimetinib [VEM+COBI], dabrafenib+trametinib [DAB+TRAM] and encorafenib+binimetinib [ENCO+BINI]) from a healthcare payer perspective in Canada... NIVO+RELA is expected to be a life-extending and cost-effective new therapy compared to SOC treatments for unresectable or metastatic melanoma in Canada.
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Opdualag (nivolumab/relatlimab) / BMS, Ono Pharma, Yervoy (ipilimumab) / Ono Pharma, BMS
Biomarker, Enrollment open, IO biomarker, Metastases: Biomarker Driven Patient Selection Neoadjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma (clinicaltrials.gov) - Mar 7, 2024
P1, N=30, Recruiting,
NIVO+RELA is expected to be a life-extending and cost-effective new therapy compared to SOC treatments for unresectable or metastatic melanoma in Canada. Not yet recruiting --> Recruiting
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Opdualag (nivolumab/relatlimab) / BMS, Ono Pharma, Yervoy (ipilimumab) / Ono Pharma, BMS
Biomarker, New P1 trial, IO biomarker, Metastases: Biomarker Driven Patient Selection Neoadjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma (clinicaltrials.gov) - Mar 6, 2024
P1, N=30, Not yet recruiting,
- |||||||||| relatlimab (BMS-986016) / BMS, Opdivo (nivolumab) / BMS
Trial completion, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Metastases: RELATIVITY-111: Study of Relatlimab in Combination With Nivolumab in Chinese Participants (clinicaltrials.gov) - Feb 19, 2024
P1, N=6, Completed,
Not yet recruiting --> Recruiting Recruiting --> Completed | N=12 --> 6 | Trial completion date: Nov 2025 --> Jan 2024 | Trial primary completion date: Nov 2025 --> Jan 2024
- |||||||||| relatlimab (BMS-986016) / BMS, Opdivo (nivolumab) / BMS
Trial completion date, Trial primary completion date, Combination therapy, Metastases: Safety Study of BMS-986016 With or Without Nivolumab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Feb 15, 2024
P1, N=35, Active, not recruiting,
Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025 Trial completion date: Sep 2023 --> Jul 2025 | Trial primary completion date: Sep 2023 --> Jul 2024
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Opdivo (nivolumab) / Ono Pharma, BMS
Journal, Metastases: Overall Survival and Response with Nivolumab and Relatlimab in Advanced Melanoma. (Pubmed Central) - Feb 10, 2024
After approximately 6 months of additional follow-up, the combination's median progression-free survival was 10.2 months versus 4.6 months for monotherapy. The difference in overall survival rates was not statistically significant.
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Journal, PD(L)-1 Biomarker, IO biomarker: Proton Craniospinal Irradiation with Immunotherapy in Two Patients with Leptomeningeal Disease from Melanoma. (Pubmed Central) - Feb 8, 2024
After pCSI with concurrent nivolumab, the addition of relatlimab, and BRAF-targeted therapy, he remained alive 7 months after LMD diagnosis despite central nervous system progression...He received pCSI with concurrent ipilimumab and nivolumab, then nivolumab maintenance...Adding an ICI to pCSI is feasible for patients with LMD and demonstrates a tolerable toxicity profile. While prospective evaluation is ultimately warranted, pCSI with ICI may confer survival benefits, even after prior ICI.
- |||||||||| Clinical, Journal, Checkpoint inhibition, PD(L)-1 Biomarker, IO biomarker, Checkpoint block, Immuno-oncology: Combinatorial immune checkpoint blockade increases myocardial expression of NLRP-3 and secretion of H-FABP, NT-Pro-BNP, interleukin-1? and interleukin-6: biochemical implications in cardio-immuno-oncology. (Pubmed Central) - Feb 7, 2024
levels were also increased by PDL-1/CTLA-4 and PD-1/LAG-3 combined blocking agents compared to untreated cells and monotherapies. Data of the present study, although in vitro, indicate that combinatorial immune checkpoint blockade, induce a pro- inflammatory phenotype, thus indicating that these therapies should be closely monitored by the multidisciplinary team consisting of oncologists, cardiologists and immunologists.
- |||||||||| relatlimab (BMS-986016) / BMS, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Metastases: Personalized Immunotherapy in Patients With Recurrent /Metastatic SCCHN That Have Progressed on Prior Immunotherapy (clinicaltrials.gov) - Feb 7, 2024
P2, N=20, Active, not recruiting,
Data of the present study, although in vitro, indicate that combinatorial immune checkpoint blockade, induce a pro- inflammatory phenotype, thus indicating that these therapies should be closely monitored by the multidisciplinary team consisting of oncologists, cardiologists and immunologists. Recruiting --> Active, not recruiting | N=40 --> 20 | Trial completion date: Aug 2029 --> Aug 2024 | Trial primary completion date: Aug 2029 --> Aug 2023
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Opdivo (nivolumab) / Ono Pharma, BMS
COMBINATORIAL IMMUNE CHECKPOINT BLOCKADE INCREASES MYOCARDIAL SECRETION OF H-FABP, NT-PRO-BNP, NLRP-3 INFLAMMASOME, INTERLEUKIN-1? AND INTERLEUKIN-6: BIOCHEMICAL IMPLICATIONS IN CARDIO-IMMUNO-ONCOLOGY (Moderated Poster Theater 09) - Jan 26, 2024 - Abstract #ACC2024ACC_6992;
Monoclonal antibodies against CTLA-4 or PD-1 or PDL-1 are the most studied ICIs in randomized clinical trials, however, more recently, an anti-LAG3 (Lymphocyte activation gene-3) human monoclonal antibody, Relatlimab, has been approved by FDA for combinatorial treatment with Nivolumab for metastatic melanoma. Data of the present study indicate that combinatorial immune checkpoint blockade, induce a pro- inflammatory phenotype, thus indicating that these therapies should be closely monitored by the multidisciplinary team consisting of oncologists, cardiologists and immunologists.
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma
Review, Journal: Relatlimab: a novel drug targeting immune checkpoint LAG-3 in melanoma therapy. (Pubmed Central) - Jan 25, 2024
On 18 March 2022, the U.S. FDA approved the fixed-dose combination of relatlimab developed by Bristol Myers Squibb with nivolumab, under the brand name Opdualag for the treatment of unresectable or metastatic melanoma in adult and pediatric patients aged 12 and older. This study comprehensively describes the mechanism of action and clinical trials of relatlimab and a brief overview of immune checkpoint drugs currently used for the treatment of melanoma.
- |||||||||| relatlimab (BMS-986016) / BMS, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date, Combination therapy, Tumor mutational burden, IO biomarker: Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer (clinicaltrials.gov) - Jan 11, 2024
P2, N=80, Recruiting,
Trial completion date: Apr 2024 --> Apr 2025 | Trial primary completion date: Dec 2023 --> Dec 2024 Trial completion date: Jul 2025 --> Sep 2027 | Trial primary completion date: May 2025 --> May 2027
- |||||||||| Review, Journal, PD(L)-1 Biomarker, IO biomarker, Metastases: Single agent vs combination immunotherapy in advanced melanoma: a review of the evidence. (Pubmed Central) - Jan 9, 2024
Trial completion date: Jul 2025 --> Sep 2027 | Trial primary completion date: May 2025 --> May 2027 These new plethora of options pose new challenges not only for optimal treatment sequencing strategies but especially for management of adverse effects, endorsing the need to integrate a holistic and personalized approach for patient care.
- |||||||||| nelitolimod (SD-101) / TriSalus Life Sci, UT MD Anderson Cancer Center
Enrollment closed, Combination therapy, Checkpoint inhibition, Checkpoint block, Metastases, Immuno-oncology: TS-PERIO-01: Intrahepatic Delivery of SD-101 by Pressure-Enabled Regional Immuno-oncology (PERIO), With Checkpoint Blockade in Adults With Metastatic Uveal Melanoma (clinicaltrials.gov) - Dec 25, 2023
P1, N=80, Active, not recruiting,
These new plethora of options pose new challenges not only for optimal treatment sequencing strategies but especially for management of adverse effects, endorsing the need to integrate a holistic and personalized approach for patient care. Recruiting --> Active, not recruiting
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Opdivo (nivolumab) / Ono Pharma, BMS
Journal, PD(L)-1 Biomarker, IO biomarker: Immune microenvironment of basal cell carcinoma and tumor regression following combined PD-1/LAG-3 blockade. (Pubmed Central) - Dec 20, 2023
Additionally, we present a patient with locally-advanced BCC who experienced stable disease during and after 45 weeks of first-line anti-PD-1 (nivolumab), followed by a partial response after the addition of anti-LAG-3 (relatlimab). Longitudinal biopsies throughout the treatment course showed a graduated increase in LAG-3 expression after anti-PD-1 therapy, lending support for coordinated immunosuppression and suggesting LAG-3 as a co-target for combination therapy to augment the clinical impact of anti-PD-(L)1.
- |||||||||| Opdivo (nivolumab) / BMS
Trial completion date, Combination therapy, Metastases: CheckMate 142: A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread (clinicaltrials.gov) - Dec 15, 2023
P2, N=385, Active, not recruiting,
Longitudinal biopsies throughout the treatment course showed a graduated increase in LAG-3 expression after anti-PD-1 therapy, lending support for coordinated immunosuppression and suggesting LAG-3 as a co-target for combination therapy to augment the clinical impact of anti-PD-(L)1. Trial completion date: Dec 2024 --> Feb 2024
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