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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
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 belowSelect...
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:Select...
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
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 moreSide effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Headache
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
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
Biospecimen Collection
2004
Completed Phase 3
~2020
Cabozantinib S-malate
2013
Completed Phase 2
~470
Nivolumab
2014
Completed Phase 3
~5220
Paclitaxel
2011
Completed Phase 4
~5810
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,855 Previous Clinical Trials
41,005,987 Total Patients Enrolled
Juneko E Grilley-OlsonPrincipal InvestigatorAlliance for Clinical Trials in Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently taking aspirin (more than 81 mg/day) or any blood thinners.I am fully active or can carry out light work.Your platelet count is at least 100,000 per cubic millimeter.Your bilirubin levels must be within a certain range, unless you have Gilbert's disease, in which case a higher level is allowed.I do not have any serious wounds that are not healing.Your hemoglobin level is at least 9.0 grams per deciliter.I haven't had any cancer except for skin cancer in the last 5 years.I can provide slides of my tumor for review.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have never been treated with PD-1 or PD-L1 inhibitors.My cancer is an angiosarcoma caused by radiation.I am not pregnant or nursing and, if capable of becoming pregnant, I have a recent negative pregnancy test.I finished all cancer treatments at least 7 days ago, except for prostate cancer treatment which can continue.I have never received VEGF TKI therapy.Your kidneys are working well enough, with a certain level of creatinine clearance.I do not have uncontrolled brain tumors.My liver function tests are within the required range and I don't have severe liver disease.I am not on high-dose steroids or other immune-weakening drugs.You can join the study if you have certain conditions like vitiligo, type I diabetes, or psoriasis that doesn't need strong medication.I have recovered from previous cancer treatment side effects, except for possible mild fatigue or hair loss.I haven't had a blood clot in the past month.My kidney function test for protein is within normal limits.I don't have any serious illnesses that would make this study unsafe for me.I am not allergic to paclitaxel, cabozantinib, nivolumab, or their ingredients.I haven't had major surgery, except for a biopsy, in the last 28 days.My angiosarcoma can't be cured with surgery or I've chosen not to undergo curative treatment.I am HIV-positive, on treatment, and my viral load is undetectable.I do not have untreated spinal issues related to my cancer.I have never been treated with taxane for my angiosarcoma.I am not on certain blood thinners but can use low-dose heparin unless I have brain metastases or bleeding issues.I haven't had serious heart issues or strokes in the last 3 months.I can speak and understand English or Spanish well enough to complete required forms.I am not taking strong CYP3A4 inhibitors or inducers, or can stop them as required before joining the study.I do not have any planned pain relief procedures like radiation or surgery.My cancer can be measured and has grown after my last cancer treatment.I have a history of cancer.I am 18 years old or older.I have had a condition where my lymphocytes multiply unusually.You have enough infection-fighting white blood cells in your body.I have not experienced significant nerve pain or damage.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (nivolumab, paclitaxel)
- Group 2: Arm II (paclitaxel)
- Group 3: Arm III (nivolumab, cabozantinib S-malate)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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