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Alkylating agents
Relatlimab + Nivolumab + Chemotherapy for Lung Cancer
Phase 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
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of less than or equal to 1 at screening and confirmed prior to randomization
No prior systemic anti-cancer treatment (including epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors) given as primary therapy for advanced or metastatic disease
Must not have
Participants with EGFR, ALK, ROS-1, or known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF V600E) mutations that are sensitive to available targeted therapy
Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new treatment combining two immunotherapy drugs (relatlimab and nivolumab) with standard chemotherapy. It targets patients with advanced or recurrent lung cancer. The goal is to see if this combination improves outcomes compared to using just one immunotherapy drug with chemotherapy. Nivolumab has shown improved survival in the treatment of advanced non-small-cell lung cancer (NSCLC) previously treated with chemotherapy.
Who is the study for?
This trial is for adults with Stage IV or recurrent non-small cell lung cancer (NSCLC) who haven't had systemic anti-cancer treatment for advanced disease. They should have a good performance status, meaning they're fairly active and can care for themselves. People with certain gene mutations treatable by targeted therapy, untreated brain metastases, another active cancer, or previous immunotherapy are excluded.
What is being tested?
The study tests the effectiveness of Relatlimab combined with Nivolumab and chemotherapy versus just Nivolumab with chemotherapy in treating NSCLC. It aims to see if adding Relatlimab improves response rates compared to the current standard which includes Nivolumab.
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in various organs like lungs or intestines, skin rashes, hormone gland problems (like thyroid), fatigue, nausea from chemotherapy drugs used alongside these treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or have some restrictions but can still care for myself.
Select...
I haven't received any systemic anti-cancer treatments for my advanced cancer.
Select...
My lung cancer is confirmed to be advanced or has come back and is either SQ or NSQ type.
Select...
My cancer can be measured on scans.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer has specific mutations (EGFR, ALK, ROS-1, BRAF V600E) treatable with targeted therapy.
Select...
I have previously been treated with specific immunotherapy drugs.
Select...
My cancer has spread to the lining of my brain and spinal cord.
Select...
I have brain metastases that have not been treated.
Select...
I do not have any other cancers needing treatment or that were active in the last 2 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent clinical review (BICR)
Treatment-related adverse events (TRAEs) leading to discontinuation within 12 weeks after the first dose
Secondary study objectives
Duration of Response (DoR) per RECIST v1.1 by BICR
Incidence of Adverse Events (AEs)
Incidence of Immune-mediated Adverse Events (IMAEs)
+6 moreSide effects data
From 2023 Phase 1 & 2 trial • 62 Patients • NCT0331061971%
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%
Hypercalcaemia
6%
Atrial fibrillation
6%
Extrasystoles
6%
Blood creatinine increased
6%
Appetite disorder
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
4Treatment groups
Experimental Treatment
Active Control
Group I: Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)Experimental Treatment6 Interventions
Group II: Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))Experimental Treatment7 Interventions
Group III: Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))Experimental Treatment7 Interventions
Group IV: Part 2: Arm D (Nivolumab + PDCT)Active Control5 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~3120
Paclitaxel
2011
Completed Phase 4
~5810
Nab-Paclitaxel
2014
Completed Phase 3
~4540
Pemetrexed
2014
Completed Phase 3
~5550
Carboplatin
2014
Completed Phase 3
~6120
Nivolumab
2014
Completed Phase 3
~5220
Relatlimab
2019
Completed Phase 2
~1150
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Immunotherapies such as Relatlimab and Nivolumab are pivotal in treating Non-Small Cell Lung Cancer (NSCLC) by enhancing the immune system's ability to fight cancer. Relatlimab, a LAG-3 inhibitor, prevents the suppression of T cells, while Nivolumab, a PD-1 inhibitor, stops cancer cells from evading immune detection.
These mechanisms are significant for NSCLC patients as they can lead to improved response rates and survival outcomes by enabling a more robust immune attack on cancer cells.
Large Cell Neuro-Endocrine Carcinoma of the Lung: Current Treatment Options and Potential Future Opportunities.Emerging therapeutic agents for lung cancer.
Large Cell Neuro-Endocrine Carcinoma of the Lung: Current Treatment Options and Potential Future Opportunities.Emerging therapeutic agents for lung cancer.
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,680 Previous Clinical Trials
4,124,601 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has specific mutations (EGFR, ALK, ROS-1, BRAF V600E) treatable with targeted therapy.I have previously been treated with specific immunotherapy drugs.I am fully active or have some restrictions but can still care for myself.I haven't received any systemic anti-cancer treatments for my advanced cancer.My lung cancer is confirmed to be advanced or has come back and is either SQ or NSQ type.My cancer can be measured on scans.My cancer has spread to the lining of my brain and spinal cord.To learn more about participating in a clinical trial with Bristol-Myers Squibb, please visit www.BMSStudyConnect.com.I have brain metastases that have not been treated.I do not have any other cancers needing treatment or that were active in the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))
- Group 2: Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))
- Group 3: Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)
- Group 4: Part 2: Arm D (Nivolumab + PDCT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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