What is the mechanism of action of this treatment?

Common cancer treatments include immunotherapy and chemotherapy. Immunotherapy, such as nivolumab, boosts the immune system's ability to detect and destroy cancer cells by targeting immune checkpoints like PD-1/PD-L1. Chemotherapy, including platinum-doublet chemotherapy, kills rapidly dividing cells by damaging their DNA. These mechanisms are vital for cancer patients as they provide targeted strategies to eradicate cancer cells while aiming to reduce harm to healthy cells.

What side effects are associated with this type of intervention?

Common cancer treatments, such as chemotherapy, immunotherapy, and targeted therapies, have a range of side effects. Chemotherapy often causes nausea, vomiting, hair loss, fatigue, and increased risk of infections due to lowered blood cell counts. Immunotherapy, including drugs like nivolumab, can lead to immune-related adverse effects such as colitis, pneumonitis, hepatitis, and endocrinopathies. Targeted therapies may cause side effects like skin rashes, hypertension, and diarrhea. When combined, these treatments can amplify side effects, necessitating careful management by healthcare providers.

What prior FDA approvals exist?

The FDA has approved several immunotherapies and combination therapies for cancer treatment. Notable approvals include nivolumab (Opdivo) and ipilimumab (Yervoy), which are immune checkpoint inhibitors used alone or in combination for advanced melanoma and other cancers. Pembrolizumab (Keytruda) is another checkpoint inhibitor approved for various cancers, including melanoma and head and neck cancer. Additionally, combination therapies such as nivolumab with platinum-doublet chemotherapy have been approved for non-small cell lung cancer. These treatments aim to enhance the immune system's ability to fight cancer and are similar in approach to the therapies being studied with BMS-986406.

What other types of research exist?

Promising novel alternatives to BMS-986406 for cancer patients include: 1) BMS-690514, an oral tyrosine kinase inhibitor targeting ErbB and VEGF receptors, showing safety and preliminary efficacy in advanced solid tumors. 2) MK-2206, an oral AKT inhibitor, although it has shown limited antileukemia activity, it may be considered in combination therapies. 3) Ibrutinib, a BTK inhibitor, particularly in combination with dexamethasone for multiple myeloma. 4) Pembrolizumab plus cetuximab, showing promising responses in treatment-refractory metastatic head and neck cancer. 5) Zanubrutinib, a BTK inhibitor with deeper responses in Waldenström Macroglobulinemia. These alternatives offer diverse mechanisms of action and potential efficacy in various cancer types.

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Monoclonal Antibodies

BMS-986406 + Combination Therapies for Cancer

Phase 1

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

Part 1D: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of non-squamous or squamous histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease, who have not had systemic therapy for metastatic or recurrent disease

Parts 1A, 1B, 1C: Histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent malignant tumor. Eligible tumor types are non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction, castration-resistant prostate cancer (CRPC), ovarian, squamous cell carcinoma of the head and neck (SCCHN), bladder, melanoma, mesothelioma, triple negative breast cancer (TNBC), and soft tissue sarcoma, except for participants with tumors with central nervous system (CNS) metastases as the only site of active disease

Must not have

Prior organ or tissue allograft

Untreated CNS metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called BMS-986406 alone, with an immune-boosting drug called nivolumab, or with both nivolumab and strong chemotherapy. It targets patients with advanced cancer. The goal is to see if these treatments are safe and can help stop cancer growth by boosting the immune system and killing cancer cells. Nivolumab has been used in various cancer treatments and has shown efficacy in improving survival rates, especially when combined with other therapies.

Who is the study for?

This trial is for adults with certain advanced cancers, including lung, kidney, pancreatic, and others. Participants must have a confirmed diagnosis with measurable disease and be in good physical condition. They can't join if they have untreated brain metastases, prior organ transplants or serious medical issues that aren't under control.

What is being tested?

The study tests BMS-986406 alone or combined with Nivolumab and/or platinum-doublet chemotherapy (PDCT) to see how safe it is and how well people tolerate it. It's aimed at those with advanced tumors to find better treatment options.

What are the potential side effects?

Possible side effects may include typical reactions from immunotherapy like fatigue, skin reactions, inflammation of organs as well as those related to chemotherapy such as nausea, hair loss, blood cell count changes leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have Stage IV A/B non-small cell lung cancer or recurrent disease and haven't had systemic therapy for it.

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My cancer is advanced and cannot be removed by surgery, but it hasn't spread to my brain.

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My cancer can be measured using specific medical guidelines.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received an organ or tissue transplant from another person.

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I have brain metastases that have not been treated.

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My cancer has spread to the lining of my brain and spinal cord.

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I do not have any serious or uncontrolled health conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Part 2: BMS-986406 + Nivolumab (Expansion Cohorts)Experimental Treatment2 Interventions

Group II: Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or PaclitaxelExperimental Treatment5 Interventions

Group III: Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion)Experimental Treatment2 Interventions

Group IV: Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation)Experimental Treatment2 Interventions

Group V: Part 1A: BMS-986406 (Monotherapy Dose Escalation)Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BMS-986406

2022

Completed Phase 1

~80

Nivolumab

2015

Completed Phase 3

~4010

Carboplatin

2014

Completed Phase 3

~6120

Pemetrexed

2014

Completed Phase 3

~5550

Paclitaxel

2011

Completed Phase 4

~5370

0 / 8Eligibility criteria met

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

Common cancer treatments include immunotherapy and chemotherapy. Immunotherapy, such as nivolumab, boosts the immune system's ability to detect and destroy cancer cells by targeting immune checkpoints like PD-1/PD-L1. Chemotherapy, including platinum-doublet chemotherapy, kills rapidly dividing cells by damaging their DNA. These mechanisms are vital for cancer patients as they provide targeted strategies to eradicate cancer cells while aiming to reduce harm to healthy cells.

Current trends and future directions in the genetic therapy of human neoplastic disease.