What side effects are associated with this type of intervention?

Common treatments for solid tumors, including those similar to DF6002 and Nivolumab, have a range of side effects. Chemotherapy can cause myelosuppression, gastrointestinal issues, and liver toxicity. Targeted therapies often result in skin rashes, hypertension, and fatigue. Immunotherapies, like Nivolumab, are associated with immune-related adverse events such as pneumonitis, colitis, hepatitis, and endocrinopathies. The severity and frequency of these side effects can vary based on the specific treatment and individual patient factors.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of solid tumors. Nivolumab (Opdivo) and Pembrolizumab (Keytruda) are notable examples, both targeting the PD-1 pathway to enhance the body's immune response against cancer cells. These drugs have been approved for various solid tumors, including melanoma, non-small cell lung cancer, renal cell carcinoma, and head and neck squamous cell carcinoma. Additionally, combination therapies involving immune checkpoint inhibitors, such as Nivolumab combined with Ipilimumab (Yervoy), have also received FDA approval for their enhanced anti-tumor activity in certain cancers.

What other types of research exist?

Promising novel alternatives to DF6002 for solid tumor patients include: 1) Bevacizumab, particularly for vestibular schwannomas in neurofibromatosis type 2, as it has shown efficacy and safety in multiple studies. 2) Everolimus, which has been studied in phase II trials for neurofibromatosis type 2 and progressive vestibular schwannomas. 3) Nivolumab and Ipilimumab combination therapy, which has shown positive outcomes in malignant pleural mesothelioma and metastatic melanoma. 4) Apatinib, which targets NDUFA4L2 in glioblastoma and has shown effectiveness in preclinical studies.

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Other

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

Must not have

Serious cardiac illness or medical conditions

Known diagnosis of antiphospholipid syndrome or clinically significant hereditary thrombophilia

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, DF6002, alone and with an existing drug, Nivolumab, in patients with advanced solid tumors. These patients have cancers that are hard to treat with standard methods. DF6002 might help shrink or slow down tumors, while Nivolumab boosts the immune system to fight cancer.

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.

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.

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.

Exclusion Criteria

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

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

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I have been diagnosed with a significant blood clotting disorder.

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I haven't had major surgery or taken steroids, other immune-weakening drugs, or experimental drugs in the last 28 days.

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I am not on any cancer treatments, immune therapies, or cytokine therapies except for erythropoietin.

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My cancer is growing quickly.

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

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

CBR according to RECIST 1.1 per IERC

Confirmed ORR per RECIST 1.1 per Investigator assessment

DOR according to RECIST 1.1 per IERC

+6 more

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717

80%

Fatigue

70%

Diarrhoea

70%

Headache

40%

Vomiting

40%

Aspartate aminotransferase increased

40%

Rash maculo-papular

40%

Alanine aminotransferase increased

40%

Lipase increased

30%

Partial seizures

30%

Hemiparesis

30%

Gait disturbance

30%

Fall

30%

Cough

30%

Dry skin

30%

Amylase increased

30%

Nausea

30%

Confusional state

20%

Malignant neoplasm progression

20%

Pyrexia

20%

Candida infection

20%

Mucosal infection

20%

Decreased appetite

20%

Back pain

20%

Dysphonia

20%

Hypotension

20%

Colitis

20%

Hyperthyroidism

20%

Oedema peripheral

20%

Muscular weakness

20%

Hypothyroidism

10%

Tinnitus

10%

Cushingoid

10%

Diabetic ketoacidosis

10%

Procedural haemorrhage

10%

Blood bilirubin increased

10%

Bradycardia

10%

Sinus tachycardia

10%

Hyperglycaemia

10%

Hypocalcaemia

10%

Neck pain

10%

Brain oedema

10%

Hydrocephalus

10%

Lethargy

10%

Seizure

10%

Hypertension

10%

Palpitations

10%

Cheilitis

10%

Presyncope

10%

Face oedema

10%

Oedema

10%

Conjunctivitis

10%

Enterocolitis infectious

10%

Oral candidiasis

10%

Pneumonia

10%

Sinusitis

10%

Staphylococcal infection

10%

Blood alkaline phosphatase increased

10%

Spinal pain

10%

Tremor

10%

Dizziness

10%

Dysarthria

10%

Urinary retention

10%

Dyspnoea exertional

10%

Nasal congestion

10%

Pneumonitis

10%

Dermatitis

10%

Erythema

10%

Rash

10%

Klebsiella infection

10%

Hypomagnesaemia

10%

Syncope

10%

Haemorrhage intracranial

10%

Pancreatitis

10%

Cholecystitis

10%

Upper respiratory tract infection

10%

Acute kidney injury

10%

Dermatitis bullous

10%

Lymphopenia

10%

Optic nerve disorder

10%

Visual impairment

10%

Dehydration

10%

Hypokalaemia

10%

Scoliosis

10%

Cognitive disorder

10%

Memory impairment

10%

Hallucination

10%

Insomnia

10%

Irritability

10%

Urinary incontinence

10%

Dyspnoea

10%

Dermatitis acneiform

10%

Pelvic venous thrombosis

10%

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1: Arm N1+I3

Cohort 2: Arm B

Part A Cohort 1c: Arm N3+RT+TMZ

Part A Cohort 1d: Arm N3+RT

Part B Cohort 1c: Arm N3+RT+TMZ

Part B Cohort 1d: Arm N3+RT

Cohort 1: Arm N3

Cohort 1b: Arm N3+I1

Cohort 2: Arm N3

Awards & Highlights

No Placebo-Only Group

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

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

~5220

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 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.