DF6002 + Nivolumab for Advanced Cancer

Recruiting at 65 trial locations

Overseen By Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Must be taking: Anticoagulants

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Rapidly progressive disease, cardiac illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

438 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effects of two drugs, DF6002 (an experimental treatment) and Nivolumab, for individuals with advanced solid tumors. Researchers aim to determine the effectiveness of these treatments both individually and in combination, and whether they can shrink tumors. The trial is open to those whose cancer treatments have failed or who lack other treatment options, particularly individuals with specific advanced cancers like melanoma or lung cancer. Participants should exhibit noticeable disease symptoms and meet certain health criteria. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop any current anticancer treatments, immune therapies, cytokine therapies (except erythropoietin), and systemic steroid or immunosuppressive therapies before starting the study. If you are on anticoagulants due to a high risk of blood clots, you may need to continue them.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that DF6002, when used alone, can cause common side effects such as tiredness, diarrhea, nausea, and skin rash. There is also a chance of side effects affecting the immune system. However, detailed safety information about using DF6002 with Nivolumab is not yet available.

Nivolumab is a well-known cancer treatment used for various conditions, providing some understanding of its safety. Since this trial is in an early stage, researchers are still carefully studying the treatment's safety. Participants in these trials are closely monitored to assess their response to the treatment and to identify any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about DF6002 combined with Nivolumab for treating advanced cancers because it offers a novel approach compared to current options like chemotherapy and traditional immunotherapy. DF6002 works by enhancing the body's immune response against cancer cells, potentially boosting the effectiveness of Nivolumab, a well-known immune checkpoint inhibitor. This combination could provide a more potent attack on cancer cells, possibly leading to better outcomes for patients. Additionally, the flexibility in administration, either subcutaneously or intravenously, offers convenience and adaptability for different patient needs.

What evidence suggests that this trial's treatments could be effective for advanced cancer?

Research has shown that DF6002 may help treat advanced solid tumors. Early studies suggest it can fight tumors independently. In this trial, some participants will receive DF6002 as monotherapy. Nivolumab, a drug already approved for advanced melanoma, has been proven to extend patient survival. Other participants in this trial will receive a combination of DF6002 with Nivolumab. Combining these two drugs might enhance treatment effectiveness, as similar combinations, like Nivolumab with Ipilimumab, have shown better response rates. This suggests that using DF6002 and Nivolumab together could offer a better treatment option for cancer patients. ^{1 2 4 5 6}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Dragonfly Therapeutics

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors where standard treatments have failed or don't exist. Participants should be relatively active and well (ECOG status 0-1), show signs of cancer, and have good blood, liver, and kidney function. They can't join if they've had serious heart issues, other cancers in the last 3 years (with some exceptions), recent major surgery, or are on certain medications like steroids.

Inclusion Criteria

My condition shows signs on exams or images.

I need blood thinners for certain health risks.

My advanced cancer has no standard treatment left or treatments have failed.

Exclusion Criteria

I have not had any cancer other than my current one in the last 3 years.

I have a serious heart condition or other major health issues.

I have been diagnosed with a significant blood clotting disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive DF6002 as monotherapy or in combination with nivolumab to determine the maximum tolerated dose and recommended efficacy expansion dose

Up to 3 weeks

Weekly visits for dose-limiting toxicity assessment

Efficacy Expansion

Participants receive DF6002 in combination with nivolumab to evaluate safety, tolerability, and preliminary anti-tumor activity

Up to 2 years

Monthly visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• DF6002
• Nivolumab

Trial Overview The study is testing DF6002 alone and combined with Nivolumab to see how safe they are and how patients respond to them. Researchers want to know what levels of these drugs stay in the body, their effects on tumors, and any potential benefits for those with tough-to-treat cancers.

How Is the Trial Designed?

Group I: Safety/PK/PD / Monotherapy / Subcutaneously or Intravenously Experimental Treatment 1 Intervention

Subcutaneous portion of the study is complete. Dosing DF6002 Q4W

Group II: Safety/PK/PD / Combination / Subcutaneously or Intravenously Experimental Treatment 2 Interventions

Subcutaneous portion of the study is complete. Dosing DF6002 Q4W Dosing nivolumab Q4W

Group III: Efficacy Expansion / Combination / Subcutaneously or Intravenously / Non-Melanoma Experimental Treatment 2 Interventions

Subcutaneous portion of the study is complete. 2L+ non-melanoma skin cancer (including cSCC, BCC, and MCC) Dosing DF6002 Q4W Dosing nivolumab Q4W

Group IV: Efficacy Expansion / Combination / Subcutaneously or Intravenously / Melanoma Experimental Treatment 2 Interventions

Subcutaneous portion of the study is complete. 2L+ melanoma Dosing DF6002 Q4W Dosing nivolumab Q4W

Group V: Dose Escalation / Monotherapy / Subcutaneously or Intravenously Experimental Treatment 1 Intervention

Subcutaneous portion of the study is complete. Dosing DF6002 Q4W

Group VI: Dose Escalation / Combination / Subcutaneously or Intravenously Experimental Treatment 2 Interventions

Subcutaneous portion of the study is complete. Dosing DF6002 Q4W Dosing nivolumab Q4W

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Dragonfly Therapeutics

Lead Sponsor

Trials

4

Recruited

1,300+

Published Research Related to This Trial

In a phase 2 trial involving 117 patients with advanced, refractory squamous non-small-cell lung cancer, nivolumab demonstrated a 14.5% objective response rate, indicating its potential effectiveness as a treatment option.

The safety profile of nivolumab was manageable, with 17% of patients experiencing severe treatment-related adverse events, suggesting that while there are risks, the benefits may outweigh them for patients with limited treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial. Rizvi, NA., Mazières, J., Planchard, D., et al.[2022]

In a phase II study involving 45 patients with MSI-H/dMMR metastatic colorectal cancer, the combination of nivolumab and low-dose ipilimumab showed a high objective response rate of 69% and a disease control rate of 84%, indicating strong efficacy as a first-line treatment.

The treatment was well tolerated, with only 22% of patients experiencing grade 3-4 treatment-related adverse events, and 74% of responders maintained their response at the time of data cutoff, suggesting durability of the treatment effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-Line Nivolumab Plus Low-Dose Ipilimumab for Microsatellite Instability-High/Mismatch Repair-Deficient Metastatic Colorectal Cancer: The Phase II CheckMate 142 Study. Lenz, HJ., Van Cutsem, E., Luisa Limon, M., et al.[2022]

Nivolumab, an immune checkpoint inhibitor, significantly improved overall survival and progression-free survival compared to docetaxel in patients with advanced squamous non-small cell lung cancer (NSCLC) in the CheckMate 017 trial.

Nivolumab was better tolerated than docetaxel, with manageable adverse effects, making it a promising treatment option for patients who have already undergone chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab: a review in advanced squamous non-small cell lung cancer. Keating, GM.[2022]

Nivolumab (OPDIVO) received accelerated FDA approval for treating unresectable or metastatic melanoma based on a 31.7% objective response rate in a study of 120 patients, showing promising efficacy after prior treatments.

The treatment demonstrated durable responses, with 87% of responding patients maintaining their response for at least 6 months, although it carries risks of immune-mediated adverse reactions that were monitored in a safety assessment of 268 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab. Hazarika, M., Chuk, MK., Theoret, MR., et al.[2023]

In the Asian subpopulation with advanced non-small cell lung cancer (NSCLC) and PD-L1 expression ≥1%, patients treated with nivolumab plus ipilimumab showed significantly improved overall survival (OS) and progression-free survival (PFS) compared to those receiving chemotherapy, with a 3-year OS rate of 53% versus 37%.

The safety profile of nivolumab plus ipilimumab was manageable, with grade 3-4 treatment-related adverse events occurring in 40% of patients, similar to the 36% in the chemotherapy group, indicating no new safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-line nivolumab + ipilimumab in advanced NSCLC: CheckMate 227 subpopulation analyses in Asian patients. O'Byrne, KJ., Lee, KH., Kim, SW., et al.[2022]

Nivolumab significantly improved one-year survival rates in patients with inoperable or metastatic BRAF V600-negative melanoma compared to dacarbazine (73% vs. 42%), indicating its efficacy as a first-line treatment option.

While nivolumab shows promise for treatment-naive patients, it does not demonstrate a clear advantage over other treatments for patients who have already received therapy, and it carries a risk of serious immunological side effects in 9% of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab (OPDIVOO) BRAF V600 mutation-negative metastatic or inoperable melanoma: survival advantage. [2019]

Combining nivolumab with ipilimumab results in higher response rates in cancer treatment compared to using nivolumab alone, indicating a potentially more effective therapeutic strategy.

This combination therapy may enhance the immune response against cancer, but specific details on the number of subjects or study duration are not provided in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab plus Ipilimumab Achieves Responses in dMMR/MSI-H Tumors. [2019]

Nivolumab, a monoclonal antibody targeting the programmed death receptor-1, has shown promising efficacy in treating advanced malignant melanoma, with nearly 25% of patients achieving a partial tumor response in a phase II trial involving previously treated stage III/IV patients.

The treatment demonstrated a durable clinical benefit, with a median progression-free survival of 172 days and an acceptable safety profile, as less than 18% of patients experienced severe adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab: a review of its use in patients with malignant melanoma. Deeks, ED.[2021]

Nivolumab, an immune checkpoint inhibitor, significantly improves overall survival and progression-free survival in patients with advanced stage squamous cell non-small cell lung cancer (NSCLC) compared to docetaxel, as shown in the CHECKMATE 017 study.

The safety and tolerability of nivolumab are favorable, and interestingly, the expression of the PD-L1 ligand does not predict treatment outcomes, suggesting that other factors may influence the effectiveness of this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab in the treatment of metastatic squamous non-small cell lung cancer: a review of the evidence. Lim, JS., Soo, RA.[2018]

In a pooled analysis of 1332 patients with advanced non-small-cell lung cancer (NSCLC), the combination of nivolumab and ipilimumab showed a median overall survival (OS) of 18.6 months and a 3-year OS rate of 35%, indicating significant long-term survival benefits compared to traditional chemotherapy.

The study found that patients who responded to treatment at 6 months had markedly better survival rates, with a 3-year OS of 66% for responders, highlighting the importance of early response in predicting long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term survival with first-line nivolumab plus ipilimumab in patients with advanced non-small-cell lung cancer: a pooled analysis. Borghaei, H., Ciuleanu, TE., Lee, JS., et al.[2023]

Nivolumab, an anti-PD-1 antibody, was administered to a 63-year-old female patient with metastatic melanoma after renal transplantation, highlighting the potential for anti-tumor activity in high-risk patients, despite the challenges of concurrent immunosuppression.

The patient experienced acute renal allograft rejection and renal failure shortly after starting nivolumab, indicating significant risks associated with this treatment in transplant recipients, but she later showed a positive clinical response after re-challenging with nivolumab while on hemodialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antitumor activity of nivolumab on hemodialysis after renal allograft rejection. Ong, M., Ibrahim, AM., Bourassa-Blanchette, S., et al.[2023]

Nivolumab significantly improved overall survival and progression-free survival in patients with unresectable or metastatic melanoma compared to dacarbazine, with hazard ratios of 0.42 and 0.43 respectively, based on a trial involving 418 patients.

The most common side effects of nivolumab included fatigue, diarrhea, and rash, but it was still considered to have a favorable benefit-risk profile compared to dacarbazine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval of Nivolumab for the First-Line Treatment of Patients with BRAFV600 Wild-Type Unresectable or Metastatic Melanoma. Beaver, JA., Theoret, MR., Mushti, S., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04423029?tab=history&a=12

Record History | ver. 12: 2022-06-28 | NCT04423029 The purpose of this study is to evaluate the safety, tolerability, drug-levels, drug-effects and preliminary anti-tumor activity of DF6002 (BMS-986415) alone ...

2. withpower.com withpower.com/trial/phase-2-carcinoma-renal-cell-6-2020-2e870

DF6002 + Nivolumab for Advanced Cancer Combining nivolumab with ipilimumab results in higher response rates in cancer treatment compared to using nivolumab alone, indicating a potentially more ...

3. clinicaltrials.eu clinicaltrials.eu/inn/df6002/

DF6002: A Promising New Drug for Advanced Solid Tumors This trial aims to evaluate the safety, effectiveness, and biological impact of DF6002 when used alone or in combination with Nivolumab, a known cancer ...

4. clinicaltrials.icts.uci.edu clinicaltrials.icts.uci.edu/trial/NCT04423029

DF6002 Alone and in Combination With Nivolumab The purpose of this study is to evaluate the safety, tolerability, drug-levels, drug-effects and preliminary anti-tumor activity of DF6002 alone ...

5. clinicaltrials.eu clinicaltrials.eu/trial/study-on-df6002-and-nivolumab-for-patients-with-advanced-solid-tumors/

Study on DF6002 and Nivolumab for Patients with ... The study aims to find the most effective dose and to understand how the treatments impact the cancer's progression. This research is important for developing ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/245135

A Study of DF6002 Alone and in Combination ... The purpose of this study is to evaluate the safety, tolerability, drug-levels, drug-effects and preliminary anti-tumor activity of DF6002 ...