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RelatlimabWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)

Name (Synonyms) Correlation
drug1259 Ipilimumab Wiki 0.71
drug1610 Nivolumab Wiki 0.41
drug2197 Sarilumab Wiki 0.32

Correlated MeSH Terms (3)

Name (Synonyms) Correlation
D008545 Melanoma NIH 0.41
D045169 Severe Acute Respiratory Syndrome NIH 0.04
D018352 Coronavirus Infections NIH 0.03

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0012056 Cutaneous melanoma HPO 0.41

There are 2 clinical trials

Clinical Trials

1 A Phase 1 Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors

This study will be used to determine the safety and tolerability of BMS-986016 administered alone and in combination with Nivolumab in subjects with advanced solid tumors.

NCT02966548 Cancer Drug: Relatlimab Drug: Nivolumab

Primary Outcomes

Measure: Number of adverse events (AE)

Time: Approximately 2.2 years

Measure: Number of serious adverse events (SAE)

Time: Approximately 2.2 years

Measure: Number of deaths

Time: Approximately 2.2 years

Measure: Number of laboratory abnormalities

Time: Approximately 2.2 years

Secondary Outcomes

Measure: Maximum observed serum concentration (Cmax) of BMS-986016

Time: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up

Measure: Time of maximum observed serum concentration (Tmax) of BMS-986016

Time: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up

Measure: Trough observed serum concentration (Ctrough) of BMS-986016

Time: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up

Measure: Concentration at the end of a dosing interval (Ctau) of BMS-986016

Time: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up

Measure: Average concentration over a dosing interval [AUC(TAU)/tau] (Css,avg) of BMS-986016

Time: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up

Measure: Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986016

Time: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up

Measure: Total body clearance (CLT) of BMS-986016

Time: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up

Measure: Volume of distribution at steady state (Vss) of BMS-986016

Time: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up

Measure: Effective elimination half-life (T-HALFeff) that explains the degree of AUC accumulation observed (T-HALFeff AUC) of BMS-986016

Time: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up

Measure: Effective elimination half-life that explains the degree of Cmax accumulation observed (T-HALFeff Cmax) of BMS-986016

Time: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up

Measure: Accumulation index; ration of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC) of BMS-986016

Time: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up

Measure: Cmax accumulation index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax) of BMS-986016

Time: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up

Measure: Ctau accumulation index; ratio of Ctau at steady state to Ctau after the first dose (AI_Ctau) of BMS-986016

Time: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up

Measure: Degree of fluctuation or fluctuation index ([Cmax - Ctau]/Css,avg) (DF) of BMS-986016

Time: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up

Measure: Best overall response (BOR)

Time: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up

Measure: Duration of response (DOR)

Time: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up

Measure: Frequency of positive anti-drug antibody (ADA) to BMS-986016

Time: Cycle 1, 2, 3, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up

Measure: Frequency of positive anti-drug antibody (ADA) to Nivolumab

Time: Cycle 1, 2, 3, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up

2 A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab Administered in Combination With Ipilimumab or Ipilimumab Alone in Participants With Unresectable or Metastatic Melanoma Who Have Progressed on Anti-PD-1 Therapy

The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine the recommended dose of relatlimab in combination with ipilimumab (for dose escalation) and to evaluate the safety, tolerability, and preliminary efficacy of the recommended dose of relatlimab in combination with ipilimumab versus ipilimumab monotherapy (for dose expansion).

NCT03978611 Melanoma Drug: Relatlimab Drug: Ipilimumab
MeSH:Melanoma
HPO:Cutaneous melanoma Melanoma

Primary Outcomes

Measure: Number of Participants with Adverse Events (AEs)

Time: Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])

Measure: Number of Participants with Serious Adverse Events (SAEs)

Time: Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])

Measure: Number of Participants With Adverse Events Including Dose Limiting Toxicity

Time: Up to 28 days after last study drug dose (approximately up to 2 years)

Measure: Number of Participants with AEs resulting in Discontinuation

Time: Up to end of study (approximately 2.4 years)

Measure: Number of Participants with AEs resulting in Death

Time: Up to end of study (approximately 2.4 years)

Measure: Number of Participants with AEs resulting in Laboratory Abnormalities

Time: Up to end of study (approximately 2.4 years)

Measure: Objective Response Rate (ORR)

Time: Approximately 2.4 years

Secondary Outcomes

Measure: Duration of response (DOR)

Time: Approximately Up to 2.4 years

Measure: Median PFS

Time: 6 and 12 months

Measure: Median Overall Survival (OS)

Time: 1 and 2 years

Measure: Number of Participants with Anti-Drug Antibodies (ADA)-Positivity

Time: Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks])

Description: Progression free survival rates (PFS rates)

Measure: Progression Free Survival rates (PFS rates)

Time: at 24 weeks and at 1 year

Description: Overall Survival Rates (OS rates)

Measure: Overall Survival Rates (OS rates)

Time: at 1 year and at 2 years

Description: Objective Response Rate (ORR)

Measure: Objective Response Rate (ORR)

Time: up to 2.4 years

Related HPO nodes (Using clinical trials)

HP:0012056: Cutaneous melanoma
Genes 15
MC1R NRAS ERCC3 XPC NRAS BAP1 CDKN2A MITF CDK4 CXCR4 POLH WRN CDKN2A BRAF HRAS
Protein Mutations 13
A27L D820Y G86R L858R P1446A T790M V600D V600E V600K V600M V600R Y822D Y823D
SNP 0
HP:0002861: Melanoma
Genes 101
CHEK2 MC1R GNA11 BAP1 ERCC5 XPC NRAS PIK3CA BAP1 CDKN2A SF3B1 OCA2 KLLN TERT RAD50 RAF1 XPA RAD51C XPA ERCC3 ACD CYSLTR2 ERCC3 ERCC5 MC1R PTPN11 CDK4 MRE11 HRAS DDB2 BRIP1 NRAS XPC DMPK BRCA1 TP53 SLC45A2 CDKN2A CDKN2A BARD1 ERCC2 PALLD CDKN2A SEC23B ERCC3 NBN BAP1 MITF BRCA2 RAD51 AKT1 TP53 RNF43 GNAQ MC1R BRCA2 DDB2 PALB2 MGMT TYR TP53 TRPV3 CTSC RAD51D WRN KRAS SDHB SLC6A17 SMAD4 BAP1 ERCC6 BRAF MBTPS2 CXCR4 ERCC2 POT1 ERCC2 POLH USF3 PTEN MITF CDKN2B SDHC PERP CDK4 CHEK2 TERF2IP POT1 MDM2 TERT CDKN2A NRAS CDKN2A ERCC4 ERCC4 POLH BRCA1 PTEN BRAF SDHD PALB2
Protein Mutations 0
SNP 0