Trial Outcomes & Findings for Nivolumab Plus Relatlimab or Ipilimumab in Metastatic Melanoma Stratified by MHC-II Expression (NCT NCT03724968)

NCT ID: NCT03724968

Last Updated: 2021-04-20

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Approximately 16 months

Results posted on

2021-04-20

Participant Flow

This study stopped early due to loss of funding. Participants were recruited at Vanderbilt-Ingram Cancer Center in Nashville, TN from January 2019 to April 2020. Although there were 2 study arms (Arm A and Arm B), only 2 participants were enrolled and both were enrolled onto Arm B.

Three participants were consented to take part in this study and 1 participant was determined to be ineligible. This study closed early due to low accrual. Both participants were assigned to Arm B. Since only 2 participants were enrolled and both were on Arm B, a statistical analysis cannot be done and some outcome measures can't be reported.

Participant milestones

Participant milestones
Measure	Arm A Nivolumab and Relatlimab Nivolumab: Nivolumab will be given by vein on day 1 of each cycle. Relatlimab: Relatlimab will be given by vein on day 1 of each 28-day cycle	Arm B Nivolumab and Ipilimumab Nivolumab: Nivolumab will be given by vein on day 1 of each cycle. Ipilimumab: Ipilimumab will be given by vein on day 1 during cycles 1-4 (cycles are 21 days).
Overall Study STARTED	0	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A Nivolumab and Relatlimab Nivolumab: Nivolumab will be given by vein on day 1 of each cycle. Relatlimab: Relatlimab will be given by vein on day 1 of each 28-day cycle	Arm B Nivolumab and Ipilimumab Nivolumab: Nivolumab will be given by vein on day 1 of each cycle. Ipilimumab: Ipilimumab will be given by vein on day 1 during cycles 1-4 (cycles are 21 days).
Overall Study Insurance issues	0	1
Overall Study Study closed	0	1

Baseline Characteristics

Nivolumab Plus Relatlimab or Ipilimumab in Metastatic Melanoma Stratified by MHC-II Expression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A Nivolumab and Relatlimab Nivolumab: Nivolumab will be given by vein on day 1 of each cycle. Relatlimab: Relatlimab will be given by vein on day 1 of each 28-day cycle	Arm B n=2 Participants Nivolumab and Ipilimumab Nivolumab: Nivolumab will be given by vein on day 1 of each cycle. Ipilimumab: Ipilimumab will be given by vein on day 1 during cycles 1-4 (cycles are 21 days).	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	—	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	—	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	—	2 participants n=7 Participants	2 participants n=5 Participants

Adverse Events

Arm A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm B

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A Nivolumab and Relatlimab Nivolumab: Nivolumab will be given by vein on day 1 of each cycle. Relatlimab: Relatlimab will be given by vein on day 1 of each 28-day cycle	Arm B n=2 participants at risk Nivolumab and Ipilimumab Nivolumab: Nivolumab will be given by vein on day 1 of each cycle. Ipilimumab: Ipilimumab will be given by vein on day 1 during cycles 1-4 (cycles are 21 days).
Endocrine disorders Adrenal insufficiency	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 1 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A

Other adverse events

Additional Information

Teresa Melton

Vanderbilt University Medical Center

Phone: 6159367423

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm A Nivolumab and Relatlimab Nivolumab: Nivolumab will be given by vein on day 1 of each cycle. Relatlimab: Relatlimab will be given by vein on day 1 of each 28-day cycle	Arm B n=2 participants at risk Nivolumab and Ipilimumab Nivolumab: Nivolumab will be given by vein on day 1 of each cycle. Ipilimumab: Ipilimumab will be given by vein on day 1 during cycles 1-4 (cycles are 21 days).
Endocrine disorders Hyperthyroidism	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 1 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Endocrine disorders Hypopituitarism	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 1 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Endocrine disorders Hypothyroidism	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 1 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
General disorders Chills	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
General disorders Limb edema	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 1 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
General disorders Fatigue	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 1 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Investigations Alanine aminotransferase increased	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 2 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Investigations Aspartate aminotransferase increased	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 2 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Investigations Blood lactate dehydrogenase increased	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 1 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Investigations Weight loss	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 1 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Investigations White blood cell decreased	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 1 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Metabolism and nutrition disorders Anorexia	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	100.0% 2/2 • Number of events 3 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Metabolism and nutrition disorders Hyperglycemia	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 1 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Metabolism and nutrition disorders Hyponatremia	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 1 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Musculoskeletal and connective tissue disorders Generalized muscle weakness	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	100.0% 2/2 • Number of events 2 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Musculoskeletal and connective tissue disorders Arthralgia	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 1 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Musculoskeletal and connective tissue disorders Myalgia	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 1 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Nervous system disorders Dizziness	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	100.0% 2/2 • Number of events 2 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Nervous system disorders Dysgeusia	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 1 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Nervous system disorders Presyncope	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 1 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Psychiatric disorders Insomnia	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	100.0% 2/2 • Number of events 2 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Psychiatric disorders Anxiety	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 1 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Skin and subcutaneous tissue disorders Pruritus	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	100.0% 2/2 • Number of events 3 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Skin and subcutaneous tissue disorders Hyperhidrosis	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 1 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Skin and subcutaneous tissue disorders Rash acneiform	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 1 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Blood and lymphatic system disorders Anemia	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 2 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Gastrointestinal disorders Diarrhea	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 1 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Gastrointestinal disorders Nausea	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 1 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Respiratory, thoracic and mediastinal disorders Cough	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 1 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Respiratory, thoracic and mediastinal disorders Hoarseness	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 1 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A
Vascular disorders Hypotension	— 0/0 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A	50.0% 1/2 • Number of events 1 • Up to 17 months This study was terminated due to loss of funding and not participants were enrolled onto Arm A