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Immunotherapy Combinations for Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Available tumor tissue for biomarker analysis
Eastern Cooperative Oncology Group Performance Status (ECOG) status of 0 or 1
Must not have
History of interstitial lung disease / pneumonitis
Known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of a new immunotherapy treatment for various types of cancer.

Who is the study for?
This trial is for adults with certain advanced solid cancers that have spread and can't be removed by surgery. Participants should be relatively healthy (ECOG status of 0 or 1) and have a tumor that can be measured. They must also provide tissue samples for research. People with brain metastases, lung inflammation history, active cancer in the last two years (except some skin cancers), or recent serious neurological issues cannot join.
What is being tested?
The study tests combinations of immunotherapy drugs: relatlimab with nivolumab and BMS-986205, or relatlimab with nivolumab and ipilimumab. It aims to find out how safe these combinations are and how well they work against different types of advanced tumors in patients who haven't had immunotherapy before as well as those who have.
What are the potential side effects?
Possible side effects include immune-related reactions such as inflammation in various organs like the intestines or liver, skin rash, hormone gland problems (like thyroid dysfunction), fatigue, flu-like symptoms, infusion reactions during drug administration, and potential worsening of underlying conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have tumor tissue available for testing.
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I am fully active or can carry out light work.
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My cancer is advanced, cannot be surgically removed, and its size can be measured.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had lung inflammation or scarring before.
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My cancer has spread to my brain or is only active there.
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I haven't had encephalitis, meningitis, or uncontrolled seizures in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2023 Phase 1 & 2 trial • 62 Patients • NCT03310619
71%
White blood cell count decreased
65%
Neutrophil count decreased
59%
Anaemia
59%
Lymphocyte count decreased
53%
Platelet count decreased
41%
Cytokine release syndrome
29%
Neutropenia
29%
Decreased appetite
18%
Diarrhoea
18%
Vomiting
18%
Muscular weakness
18%
Dizziness
18%
Neurotoxicity
18%
Insomnia
18%
Pleural effusion
18%
Hypertension
12%
Pyrexia
12%
Hypoxia
12%
Febrile neutropenia
12%
Thrombocytopenia
12%
Tachycardia
12%
Conjunctival haemorrhage
12%
Fatigue
12%
Pain
12%
Contusion
12%
Hyperuricaemia
12%
Hypokalaemia
12%
Hypomagnesaemia
12%
Tremor
12%
Dyspnoea
12%
Pruritus
6%
Appetite disorder
6%
Extrasystoles
6%
Hypercalcaemia
6%
Atrial fibrillation
6%
Blood creatinine increased
6%
Enteritis
6%
COVID-19
6%
Pneumonia
6%
Agraphia
6%
Large intestine perforation
6%
Hypofibrinogenaemia
6%
Supraventricular extrasystoles
6%
Ventricular tachycardia
6%
Periorbital oedema
6%
Visual impairment
6%
Abdominal distension
6%
Abdominal pain
6%
Anal incontinence
6%
Constipation
6%
Dry mouth
6%
Gastrointestinal disorder
6%
Oedema
6%
Oedema peripheral
6%
Physical deconditioning
6%
Jaundice
6%
Ocular icterus
6%
Conjunctivitis
6%
Cytomegalovirus infection reactivation
6%
Urinary tract infection
6%
Fall
6%
Alanine aminotransferase increased
6%
Blood bilirubin increased
6%
Dehydration
6%
Hypocalcaemia
6%
Hypophosphataemia
6%
Arthralgia
6%
Musculoskeletal chest pain
6%
Amnesia
6%
Peroneal nerve palsy
6%
Anxiety
6%
Confusional state
6%
Urinary retention
6%
Cough
6%
Oropharyngeal pain
6%
Night sweats
6%
Seborrhoeic dermatitis
6%
Deep vein thrombosis
6%
Haematoma
6%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion)
Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment3 Interventions
Relatlimab + Nivolumab + Ipilimumab
Group II: Arm AExperimental Treatment3 Interventions
Relatlimab + Nivolumab + BMS-986205
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMS-986205
2017
Completed Phase 3
~1200
Ipilimumab
2015
Completed Phase 3
~3070
Relatlimab
2019
Completed Phase 2
~1150
Nivolumab
2015
Completed Phase 3
~4010

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,682 Previous Clinical Trials
4,129,292 Total Patients Enrolled

Media Library

BMS-986205 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03459222 — Phase 1 & 2
Cancer Research Study Groups: Arm A, Arm B
Cancer Clinical Trial 2023: BMS-986205 Highlights & Side Effects. Trial Name: NCT03459222 — Phase 1 & 2
BMS-986205 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03459222 — Phase 1 & 2
~58 spots leftby Nov 2026
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