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Monoclonal Antibodies

Nivolumab + Chemotherapy for Soft Tissue Sarcoma

Phase 2

Waitlist Available

Led By Juneko E Grilley-Olson

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Serious non-healing wounds unrelated to cancer are excluded

Must not have

No current use of aspirin (> 81 mg/day), or any other antiplatelet agents (Taxane Pre-treated only)

Active autoimmune disease requiring systemic treatment (i.e. disease modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years. These include but are not limited to patients with a history of immune-related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as SLE, rheumatoid arthritis, connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effectiveness of two drugs, paclitaxel and cabozantinib, in treating patients with soft tissue sarcoma. The first group of patients will receive paclitaxel, and the second group will receive paclitaxel and cabozantinib. The trial is being done to see if the combination of the two drugs can shrink the tumor and prevent it from coming back.

Who is the study for?

Adults with certain types of soft tissue sarcoma who haven't had taxane drugs or are pre-treated with them. They must be in good health, not pregnant or nursing, and without serious heart issues or recent thromboembolic events. No history of severe autoimmune diseases, uncontrolled illnesses, or hypersensitivity to the trial drugs is allowed.

What is being tested?

The effectiveness of adding Nivolumab to chemotherapy (Paclitaxel) for patients new to taxane treatment and its combination with Cabozantinib for those previously treated. The study aims to see if these combinations can shrink tumors and prevent recurrence.

What are the potential side effects?

Nivolumab may cause immune-related reactions, fatigue, skin issues, and potential complications from activating the immune system against body tissues. Paclitaxel can lead to nerve damage, allergic reactions, blood cell count changes. Cabozantinib might cause liver problems and high blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I do not have any serious wounds that are not healing.

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I can provide slides of my tumor for review.

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I have never been treated with PD-1 or PD-L1 inhibitors.

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My cancer is an angiosarcoma caused by radiation.

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I have never received VEGF TKI therapy.

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I do not have uncontrolled brain tumors.

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I haven't had a blood clot in the past month.

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I am not allergic to paclitaxel, cabozantinib, nivolumab, or their ingredients.

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I haven't had major surgery, except for a biopsy, in the last 28 days.

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I do not have untreated spinal issues related to my cancer.

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I have never been treated with taxane for my angiosarcoma.

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I haven't had serious heart issues or strokes in the last 3 months.

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I do not have any planned pain relief procedures like radiation or surgery.

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I am 18 years old or older.

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I have not experienced significant nerve pain or damage.

Exclusion Criteria

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

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I am not currently taking aspirin (more than 81 mg/day) or any blood thinners.

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I haven't needed systemic treatment for an autoimmune disease in the last 2 years.

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I have a history of cancer.

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I have had a condition where my lymphocytes multiply unusually.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Overall response rate (ORR) in angiosarcoma patients who have had prior taxane

Progression free survival (PFS) in taxane naive patients with angiosarcoma

Secondary study objectives

Incidence of adverse events

ORR in the nivolumab + paclitaxel

Overall survival in each of the 2 combination arms

+1 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729

59%

Leukopenia

56%

Neutropenia

34%

Hypoaesthesia

31%

Agranulocytosis

22%

Alopecia

22%

Asthenia

19%

Pyrexia

16%

Nail disorder

16%

Oedema peripheral

16%

Diarrhoea

16%

Hypophagia

13%

Alanine aminotransferase increased

13%

Neurotoxicity

13%

Cough

13%

Vomting

Musculoskeletal pain

Aspartate aminotransferase increased

Headache

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm III (nivolumab, cabozantinib S-malate)Experimental Treatment8 Interventions

Patients receive nivolumab IV over 30 minutes on day 1 and cabozantinib S-malate PO daily. Cycles repeat every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood at baseline and on study, CT scan, spiral CT, or MRI, or FDG-PET scan throughout the trial.

Group II: Arm II (paclitaxel)Experimental Treatment7 Interventions

Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Cycles repeat every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood at baseline and on study, CT scan, spiral CT, or MRI, or FDG-PET scan throughout the trial.

Group III: Arm I (nivolumab, paclitaxel)Experimental Treatment8 Interventions

Patients receive nivolumab IV over 30 minutes on day 1 and paclitaxel IV over 1 hour on days 1, 8, and 15. Cycles repeat every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood at baseline and on study, CT scan, spiral CT, or MRI, or FDG-PET scan throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2740

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160