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DF6002 + Nivolumab for Advanced Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Anticoagulants are required for specific risk criteria
Advanced/metastatic solid tumors, for which no standard therapy exists or standard therapy has failed among specified tumor types
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a new drug, DF6002, either alone or in combination with another drug, nivolumab, in people with advanced solid tumors.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include typical reactions related to immune therapies such as fatigue, skin rash, digestive problems like diarrhea or nausea; hormonal gland issues; inflammation in lungs or liver; infusion-related reactions; changes in blood counts 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 need blood thinners for certain health risks.
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My advanced cancer has no standard treatment left or treatments have failed.
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I am fully active or can carry out light work.

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

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with dose-limiting toxicities (DLTs)
Overall Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per an Independent Endpoint Review Committee (IERC)
Secondary outcome measures
Area under the plasma concentration-time curve from the time of dosing extrapolated to infinity (AUC 0-INF)
Area under the plasma concentration-time curve from the time of dosing to the time of the last observation (AUC 0-T)
Best overall response (BOR) according to RECIST 1.1 per Investigator assessment
+19 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Neutropenia
21%
Pyrexia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Chest pain
10%
Hypoalbuminaemia
10%
Dry skin
10%
Muscular weakness
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Hypothyroidism
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Chills
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Dry mouth
5%
Pain
5%
Malaise
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Embolism
2%
Cardiac failure
2%
Sepsis
2%
Atrial fibrillation
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
1%
Bronchial obstruction
1%
Pneumothorax
1%
Ileus
1%
Atrial flutter
1%
Bone pain
1%
Small intestinal haemorrhage
1%
Pericardial effusion
1%
Femur fracture
1%
Pancytopenia
1%
Colitis
1%
Hypercalcaemia
1%
Small intestinal obstruction
1%
Circulatory collapse
1%
Confusional state
1%
Cancer pain
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Superior vena cava syndrome
1%
Gastrointestinal haemorrhage
1%
Syncope
1%
Lung cancer metastatic
1%
Performance status decreased
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

Trial Design

6Treatment groups
Experimental Treatment
Group I: Monotherapy Dose Expansion (NSCLC)Experimental Treatment1 Intervention
Group II: Monotherapy Dose Expansion (Melanoma)Experimental Treatment1 Intervention
Group III: Monotherapy Dose EscalationExperimental Treatment1 Intervention
Group IV: Combination Dose Expansion (NSCLC)Experimental Treatment2 Interventions
Group V: Combination Dose Expansion (Melanoma)Experimental Treatment2 Interventions
Group VI: Combination Dose EscalationExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4740

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 treatments for solid tumors include immunotherapy and chemotherapy. Immunotherapy, such as the combination of DF6002 and Nivolumab, works by stimulating the body's immune system to recognize and attack cancer cells. Nivolumab is an anti-PD-1 therapy that blocks the programmed cell death protein 1 (PD-1) pathway, enhancing the immune response against tumor cells. Chemotherapy, on the other hand, uses drugs to kill rapidly dividing cancer cells or inhibit their growth. These treatments are crucial for solid tumor patients as they can reduce tumor size, slow disease progression, and improve survival rates. The potential anti-tumor activity of DF6002 in combination with Nivolumab represents a promising approach to enhance the effectiveness of immunotherapy in treating advanced solid tumors.

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,652 Previous Clinical Trials
4,130,352 Total Patients Enrolled
Dragonfly TherapeuticsLead Sponsor
3 Previous Clinical Trials
722 Total Patients Enrolled
Tapan Maniar, MDStudy DirectorDragonfly Therapeutics
1 Previous Clinical Trials
37 Total Patients Enrolled

Media Library

DF6002 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04423029 — Phase 1 & 2
Solid Tumors Research Study Groups: Monotherapy Dose Escalation, Combination Dose Escalation, Combination Dose Expansion (Melanoma), Monotherapy Dose Expansion (Melanoma), Monotherapy Dose Expansion (NSCLC), Combination Dose Expansion (NSCLC)
Solid Tumors Clinical Trial 2023: DF6002 Highlights & Side Effects. Trial Name: NCT04423029 — Phase 1 & 2
DF6002 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04423029 — Phase 1 & 2
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