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.

← Back to Search

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 2 years

Awards & highlights

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

Select...

I need blood thinners for certain health risks.

Select...

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

Select...

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:

Select...

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

Select...

I have been diagnosed with a significant blood clotting disorder.

Select...

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

Select...

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

Select...

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

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%

Dry skin

10%

Hypoalbuminaemia

10%

Muscular weakness

10%

Chest pain

10%

Dysgeusia

10%

Pneumonia

10%

Productive cough

Hypothyroidism

Abdominal pain upper

Upper respiratory tract infection

Mucosal inflammation

Peripheral sensory neuropathy

Lacrimation increased

Nasopharyngitis

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Chills

Hypertension

Bronchitis

Dehydration

Blood alkaline phosphatase increased

Hyperglycaemia

Hyperkalaemia

Lymphocyte count decreased

Anxiety

Hypophosphataemia

Leukopenia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Hypotension

Dry mouth

Pain

Malaise

Musculoskeletal chest pain

Rash maculo-papular

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Myocardial infarction

Metastases to central nervous system

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Embolism

Cardiac failure

Malignant pleural effusion

Sepsis

Atrial fibrillation

General physical health deterioration

Adrenal insufficiency

Neoplasm progression

Cancer pain

Confusional state

Circulatory collapse

Bronchial obstruction

Pneumothorax

Atrial flutter

Ileus

Bone pain

Small intestinal haemorrhage

Pericardial effusion

Femur fracture

Pancytopenia

Colitis

Small intestinal obstruction

Hypercalcaemia

Syncope

Pericardial effusion malignant

Superior vena cava syndrome

Gastrointestinal haemorrhage

Lung cancer metastatic

Performance status decreased

Respiratory tract infection

Respiratory failure

Tumour pain

Appendicitis

Skin infection

Ataxia

Seizure

100%

80%

60%

40%

20%

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

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.