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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%
Pyrexia
21%
Neutropenia
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%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
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%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Chills
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Confusional state
1%
Cancer pain
1%
Hypercalcaemia
1%
Femur fracture
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
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
~4750

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,640 Previous Clinical Trials
4,128,991 Total Patients Enrolled
Dragonfly TherapeuticsLead Sponsor
3 Previous Clinical Trials
842 Total Patients Enrolled
Tapan Maniar, MDStudy DirectorDragonfly Therapeutics

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

Frequently Asked Questions

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

Are there multiple locations in the U.S. executing this research endeavor?

"For this clinical trial, patients can be enrolled at Lifespan - The Miriam Hospital in Providence, Rhode island, Roswell Park Comprehensive Cancer Center in Salt Lake City, Utah and Augusta University Georgia Cancer Centre in Augusta, Georgia with an additional 42 sites located across the United States."

Answered by AI

What is the cap on participants in this clinical trial?

"This trial requires 473 suitable participants and is being conducted in several locations, such as Lifespan - The Miriam Hospital (Providence, Rhode island) and Roswell Park Comprehensive Cancer Center (Salt Lake City, Utah)."

Answered by AI

Is this an experimental clinical trial?

"DF6002 has been undergoing trials since 2012, when it was initially sponsored by Ono Pharmaceutical Co. Ltd. After a successful Phase 1 and 2 approval process following the 659-participant trial in 2012, there are now 718 live studies being conducted across 49 nations with sites in 2356 cities."

Answered by AI

Are there any unfilled slots in this clinical trial?

"Affirmative. The information on clinicaltrials.gov reveals that this investigation is seeking participants, having been first posted on July 10th 2020 and last amended November 1st 2022. 473 patients are needed for the trial which will take place in 42 different medical institutions."

Answered by AI

What primary applications does DF6002 have?

"DF6002 is a commonly prescribed medication for treating malignant neoplasms. It has further shown promise in assisting with the management of unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI

What prior research has been conducted regarding DF6002?

"DF6002 was first tested in 2012 at Local Institution. Presently, 252 studies have been finished and 718 are presently enrolling participants primarily from Providence, Rhode island."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of DF6002 Alone and in Combination With Nivolumab
2020. "A Study of DF6002 Alone and in Combination With Nivolumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04423029.
All > Metastatic Triple Negative Breast Cancer > Endometrial Cancer
~20 spots leftby Jul 2024
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