DF6002 for Melanoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Melanoma+11 MoreDF6002 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Melanoma
  • Head and Neck Squamous Cell Carcinoma (HNSCC)
  • Esophageal Cancer
  • Breast Cancer
  • Kidney Cancer
  • Bladder Cancer
  • Lung Cancer
  • Endometrial Cancer
  • Stomach Cancer
  • Ovarian Cancer
  • Prostate Cancer
  • Solid Tumors

Treatment Effectiveness

Study Objectives

5 Primary · 28 Secondary · Reporting Duration: Approximately one year

Approximately one year
Best overall response (BOR) according to RECIST 1.1 per Investigator assessment
Week 3
Number of participants with dose-limiting toxicities (DLTs)
Week 3
Assessment of the number of dose limiting toxicities experienced on study with combination therapy of DF6002 and nivolumab as defined per criteria in the study protocol
Week 3
Assessment of the number of dose limiting toxicities experienced on study with monotherapy DF6002 as defined per criteria in the study protocol
Day 28
Determine serum concentrations of DF6002 at various timepoints
Month 24
Assess Duration of Response
Year 1
Assess Best Overall Response
Year 1
Assess overall response rate
Year 2
Assess Overall Survival
Year 2
Assess Overall Response Rate
Day 30
Assess number of treatment emergent adverse events throughout study
Up to 2 years
CBR according to RECIST 1.1 per IERC
Clinical benefit rate (CBR) according to RECIST 1.1 per Investigator assessment
Confirmed ORR per RECIST 1.1 per Investigator assessment
Duration of TEAEs
Number of participants with changes from baseline in Eastern Cooperative Oncology Group (ECOG) performance status
Number of participants with changes from baseline in clinical laboratory parameters
Number of participants with changes from baseline in electrocardiogram (ECG) parameters
Number of participants with changes from baseline in vital sign parameters
Number of participants with treatment emergent adverse events (TEAEs)
Overall Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per an Independent Endpoint Review Committee (IERC)
PFS according to RECIST 1.1 per IERC
Progression-free survival (PFS) according to RECIST 1.1 per Investigator assessment
Serum titers of anti-DF6002 antibodies
Serum titers of anti-nivolumab antibodies
Severity of TEAEs
Unconfirmed response after 4 cycles according to RECIST 1.1
Up to 5 years
Overall Survival (OS)
Up to day 28
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)
Maximum serum concentration observed post-dose (Cmax)
Up to month 24
DOR according to RECIST 1.1 per IERC
Duration of Response (DOR) according to RECIST 1.1 per Investigator assessment

Trial Safety

Side Effects for

NIVOLUMAB 3 mg/kg
38%Fatigue
29%Nausea
28%Decreased appetite
25%Cough
25%Diarrhoea
24%Dyspnoea
20%Vomiting
19%Constipation
14%Anaemia
14%Weight decreased
13%Malignant neoplasm progression
13%Aspartate aminotransferase increased
13%Arthralgia
13%Back pain
13%Pruritus
12%Pyrexia
12%Rash
11%Oedema peripheral
10%Dizziness
10%Myalgia
10%Productive cough
10%Abdominal pain
9%Non-cardiac chest pain
9%Alanine aminotransferase increased
9%Hypoalbuminaemia
9%Hyponatraemia
9%Headache
8%Asthenia
7%Hypothyroidism
7%Upper respiratory tract infection
7%Hypokalaemia
7%Musculoskeletal pain
6%Insomnia
6%Chills
6%Nasopharyngitis
6%Lymphocyte count decreased
6%Blood alkaline phosphatase increased
6%Hyperglycaemia
6%Musculoskeletal chest pain
6%Pain in extremity
6%Haemoptysis
6%Dry skin
6%Dyspepsia
5%Dysgeusia
5%Hypomagnesaemia
5%Rash maculo-papular
4%Pneumonia
4%Blood creatinine increased
4%Muscular weakness
3%Stomatitis
3%Chest pain
3%Hypophosphataemia
3%Dysphonia
3%Pneumonitis
2%Pleural effusion
2%Pulmonary embolism
2%Mucosal inflammation
2%Peripheral sensory neuropathy
2%Alopecia
2%Lung infection
2%Pericardial effusion malignant
2%Epistaxis
1%Acute coronary syndrome
1%Adrenal insufficiency
1%General physical health deterioration
1%Hypersensitivity
1%Urinary tract infection
1%Hip fracture
1%Infusion related reaction
1%Gamma-glutamyltransferase increased
1%Dehydration
1%Hypercalcaemia
1%Pathological fracture
1%Malignant pleural effusion
1%Cancer pain
1%Lung neoplasm malignant
1%Cerebrovascular accident
1%Confusional state
1%Metastases to spine
1%Syncope
1%Chronic obstructive pulmonary disease
1%Renal failure
1%Pneumothorax
1%Respiratory failure
1%Pulmonary haemorrhage
1%Deep vein thrombosis
1%Lacrimation increased
1%Neutropenia
1%Thrombocytopenia
1%Platelet count decreased
1%Neutrophil count decreased
1%Colitis
1%Cholecystitis acute
1%Sepsis
1%Lower respiratory tract infection
1%Metastases to central nervous system
1%Tumour pain
1%Seizure
1%White blood cell count decreased
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT02041533) in the NIVOLUMAB 3 mg/kg ARM group. Side effects include: Fatigue with 38%, Nausea with 29%, Decreased appetite with 28%, Cough with 25%, Diarrhoea with 25%.

Trial Design

12 Treatment Groups

DF6002 Monotherapy Expansion (NSCLC)
1 of 12
DF6002 in Combination with Opdivo Expansion (Melanoma)
1 of 12
DF6002 Monotherapy Dose Escalation
1 of 12
DF6002 in Combination with Opdivo Expansion (NSCLC)
1 of 12
DF6002 Monotherapy Expansion (Melanoma)
1 of 12
DF6002 In Combination with Opdivo Escalation
1 of 12
Combination Dose Expansion (Melanoma)
1 of 12
Combination Dose Expansion (NSCLC)
1 of 12
Monotherapy Dose Expansion (Melanoma)
1 of 12
Monotherapy Dose Expansion (NSCLC)
1 of 12
Monotherapy Dose Escalation
1 of 12
Combination Dose Escalation
1 of 12

Experimental Treatment

473 Total Participants · 12 Treatment Groups

Primary Treatment: DF6002 · No Placebo Group · Phase 1 & 2

DF6002 Monotherapy Expansion (NSCLC)
Drug
Experimental Group · 1 Intervention: DF6002 · Intervention Types: Drug
DF6002 in Combination with Opdivo Expansion (Melanoma)Experimental Group · 2 Interventions: Nivolumab, DF6002 · Intervention Types: Drug, Drug
DF6002 Monotherapy Dose Escalation
Drug
Experimental Group · 1 Intervention: DF6002 · Intervention Types: Drug
DF6002 in Combination with Opdivo Expansion (NSCLC)Experimental Group · 2 Interventions: Nivolumab, DF6002 · Intervention Types: Drug, Drug
DF6002 Monotherapy Expansion (Melanoma)
Drug
Experimental Group · 1 Intervention: DF6002 · Intervention Types: Drug
DF6002 In Combination with Opdivo EscalationExperimental Group · 2 Interventions: Nivolumab, DF6002 · Intervention Types: Drug, Drug
Combination Dose Expansion (Melanoma)Experimental Group · 2 Interventions: Nivolumab, DF6002 · Intervention Types: Drug, Drug
Combination Dose Expansion (NSCLC)Experimental Group · 2 Interventions: Nivolumab, DF6002 · Intervention Types: Drug, Drug
Monotherapy Dose Expansion (Melanoma)
Drug
Experimental Group · 1 Intervention: DF6002 · Intervention Types: Drug
Monotherapy Dose Expansion (NSCLC)
Drug
Experimental Group · 1 Intervention: DF6002 · Intervention Types: Drug
Monotherapy Dose Escalation
Drug
Experimental Group · 1 Intervention: DF6002 · Intervention Types: Drug
Combination Dose EscalationExperimental Group · 2 Interventions: Nivolumab, DF6002 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately one year

Who is running the clinical trial?

Dragonfly TherapeuticsLead Sponsor
2 Previous Clinical Trials
852 Total Patients Enrolled
Bristol-Myers SquibbLead Sponsor
2,501 Previous Clinical Trials
3,927,761 Total Patients Enrolled
176 Trials studying Melanoma
58,207 Patients Enrolled for Melanoma
Tapan Maniar, MDStudy DirectorDragonfly Therapeutics

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The following tumor types are advanced/metastatic and for which no standard therapy exists or standard therapy has failed.
You have no signs or symptoms of cancer.
You have clinical or radiological evidence of disease.