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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights

Study Summary

This trial is testing if a new cancer treatment is more effective and has a better safety profile than the current standard of care.

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.Check my eligibility
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.See study design
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 below
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I am fully active or have some restrictions but can still care for myself.
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I haven't received any systemic anti-cancer treatments for my advanced cancer.
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My lung cancer is confirmed to be advanced or has come back and is either SQ or NSQ type.
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My cancer can be measured on scans.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Duration of Response (DoR) per RECIST v1.1 by BICR
Incidence of Adverse Events (AEs)
Incidence of Immune-mediated Adverse Events (IMAEs)
+6 more

Side effects data

From 2023 Phase 1 & 2 trial • 62 Patients • NCT03310619
36%
Nausea
36%
Vomiting
36%
Thrombocytopenia
27%
Fatigue
27%
Leukopenia
27%
Anaemia
27%
Hypokalaemia
18%
Hyperbilirubinaemia
18%
Neutropenia
18%
Insomnia
18%
Nasal discomfort
18%
Rash
18%
Hypomagnesaemia
18%
Musculoskeletal chest pain
9%
Encephalopathy
9%
Respiratory syncytial virus infection
9%
Upper respiratory tract infection
9%
Ileus paralytic
9%
Enterocolitis
9%
Pyrexia
9%
Back pain
9%
Cellulitis
9%
Acute kidney injury
9%
Rash maculo-papular
9%
Abdominal pain
9%
Lymphopenia
9%
Pain
9%
Hypogammaglobulinaemia
9%
Cough
9%
Aspartate aminotransferase increased
9%
Hyponatraemia
9%
Headache
9%
Hypophosphataemia
9%
Dysphonia
9%
Oropharyngeal pain
9%
Hiatus hernia
9%
Arthralgia
9%
Nystagmus
9%
Febrile neutropenia
9%
Bloody discharge
9%
Hypertension
9%
Sepsis
9%
Neurotoxicity
9%
Acute respiratory failure
9%
Chapped lips
9%
Alanine aminotransferase increased
9%
Squamous cell carcinoma of skin
9%
Asthenia
9%
Pneumonia
9%
Blood alkaline phosphatase increased
9%
Hypocalcaemia
9%
Muscular weakness
9%
Rhinorrhoea
9%
Abdominal pain upper
9%
Hypertriglyceridaemia
9%
Productive cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion)
Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)

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
~1940
Paclitaxel
2011
Completed Phase 4
~5380
Nab-Paclitaxel
2014
Completed Phase 3
~4340
Pemetrexed
2014
Completed Phase 3
~5250
Carboplatin
2014
Completed Phase 3
~6670
Nivolumab
2014
Completed Phase 3
~4750
Relatlimab
2018
Completed Phase 2
~1120

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,080 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04623775 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT)), Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT)), Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT), Part 2: Arm D (Nivolumab + PDCT)
Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04623775 — Phase 2
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04623775 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you share any other relevant research that has been done on Relatlimab?

"Relatlimab was first studied in 1997 and, 2624 clinical trials later, is still being researched. Right now, 2289 medical studies are actively recruiting patients; a significant portion of these trials taking place near Natrona Heights, Pennsylvania."

Answered by AI

Are there any vacancies in this research project for new participants?

"That is accurate. The clinical trial, which began recruiting on February 17th 2021, is still looking for patients. So far, 49 sites have been utilized in the search for 420 individuals."

Answered by AI

What autoimmune diseases does Relatlimab commonly help manage?

"Relatlimab is used to fight cancerous neoplasms. In addition, it can be employed to treat other conditions such as melanoma that cannot be removed by surgery, squamous cell carcinoma, and locally advanced nonsquamous non-small cell lung cancer."

Answered by AI

What is the projected or estimated number of people who will enroll in this clinical trial?

"To run this clinical trial, we need 420 volunteers that fit the predetermined patient profile. Those who participate can do so from different hospitals, such as Allegheny Valley Hospital located in Natrona Heights, Pennsylvania or Duke University Medical Center situated in Durham, North carolina."

Answered by AI

What are the parameters of success for this experiment?

"The primary outcome that will be observed and compared over a 10 to 21-month period is the Overall Response Rate (ORR) as measured by RECIST v1.1. This study's secondary outcomes include the Duration of Response (DoR), Treatment Related Adverse Events (TRAEs), and PFS in biomarker subgroups, all as defined by Part 2 of this trial."

Answered by AI

When will Relatlimab be available for public use?

"Since this is a Phase 2 trial, meaning that while there is some safety data it has not been proven effective, we have given Relatlimab a score of 2."

Answered by AI

Is this trial also taking place in other locations besides this city?

"Enrollment for this trial is currently happening at 49 different locations, which include cities such as Natrona Heights, Durham and Athens. Travel can be a burden, so please enroll at the location that is most convenient for you."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Local Institution
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)
2021. "A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04623775.
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~11 spots leftby May 2024
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