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Monoclonal Antibodies

Nivolumab + Chemotherapy for Soft Tissue Sarcoma

Q: Are there different research centers participating in this trial throughout the US?

<p>Queen's <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center - Kuakini in Honolulu, <a href="https://www.withpower.com/clinical-trials/hawaii">Hawaii</a>, Smilow Cancer Hospital-Orange Care Center in Orange, <a href="https://www.withpower.com/clinical-trials/connecticut">Connecticut</a> and Siteman Cancer Center at Christian Hospital in Saint Louis, <a href="https://www.withpower.com/clinical-trials/missouri">Missouri</a> are a few of the 100+ locations where patients can enroll in this study.</p>

Q: Can you explain what Paclitaxel is most often used to treat?

<p>Various forms of aggressive <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a>, such as unresectable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a> and <a href="https://www.withpower.com/clinical-trials/squamous-cell-carcinoma">squamous cell carcinoma</a>, can be mitigated through Paclitaxel treatment.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 am not pregnant or nursing and, if capable of becoming pregnant, I have a recent negative pregnancy test.

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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 am not on high-dose steroids or other immune-weakening drugs.

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I finished all cancer treatments at least 7 days ago, except for prostate cancer treatment which can continue.

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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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My liver function tests are within the required range and I don't have severe liver disease.

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I have recovered from previous cancer treatment side effects, except for possible mild fatigue or hair loss.

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

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My kidney function test for protein is within normal limits.

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I don't have any serious illnesses that would make this study unsafe for me.

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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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My angiosarcoma can't be cured with surgery or I've chosen not to undergo curative treatment.

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I am HIV-positive, on treatment, and my viral load is undetectable.

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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 am not taking strong CYP3A4 inhibitors or inducers, or can stop them as required before joining the study.

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

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My cancer can be measured and has grown after my last cancer treatment.

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I am 18 years old or older.

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I have not experienced significant nerve pain or damage.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

Incidence of adverse events

ORR in the nivolumab + paclitaxel

Overall survival in each of the 2 combination arms

+2 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%

Neurotoxicity

13%

Alanine aminotransferase increased

13%

Cough

13%

Vomting

Headache

Musculoskeletal pain

Aspartate aminotransferase increased

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

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

Biospecimen Collection

2004

Completed Phase 2

~1730

Computed Tomography

2017

Completed Phase 2

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Cabozantinib S-malate

2013

Completed Phase 2

~470

Nivolumab

2014

Completed Phase 3

~4750

Paclitaxel

2011

Completed Phase 4

~5380

0 / 27Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,657 Previous Clinical Trials

40,933,577 Total Patients Enrolled

Juneko E Grilley-OlsonPrincipal InvestigatorAlliance for Clinical Trials in Oncology

Media Library

Nivolumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04339738 — Phase 2

Skin Angiosarcoma Research Study Groups: Arm I (nivolumab, paclitaxel), Arm II (paclitaxel), Arm III (nivolumab, cabozantinib S-malate)

Skin Angiosarcoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT04339738 — Phase 2

Nivolumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04339738 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people still being enrolled in this experiment?

"This clinical trial is currently recruiting patients, according to the information available on clinicaltrials.gov. The original posting date for the trial was 9/4/2020, and it was last updated on 11/16/2022."

Answered by AI

Are there different research centers participating in this trial throughout the US?

"Queen's Cancer Center - Kuakini in Honolulu, Hawaii, Smilow Cancer Hospital-Orange Care Center in Orange, Connecticut and Siteman Cancer Center at Christian Hospital in Saint Louis, Missouri are a few of the 100+ locations where patients can enroll in this study."

Answered by AI

How many people have signed up to participate in this experiment?

"That is correct, the online information does show that this study requires participants. The listing was created on September 4th 2020 with the most recent update being November 16th 2022. They are 90 patients needed in total from 100 hospitals or research centres."

Answered by AI

Can you explain what Paclitaxel is most often used to treat?

"Various forms of aggressive cancer, such as unresectable melanoma and squamous cell carcinoma, can be mitigated through Paclitaxel treatment."

Answered by AI

What is the precedence of Paclitaxel in medical research?

"City of Hope Comprehensive Cancer Center first researched paclitaxel in 1997 and, since then, 1644 completed trials have yielded data. As of now, there are 1657 ongoing clinical trials; a considerable number of these studies take place in Honolulu, Hawaii."

Answered by AI

Has Paclitaxel been cleared by the FDA?

"Paclitaxel is still being clinically tested for both efficacy and safety. Right now, there is some evidence to support its safety, but none to suggest that it actually works. Our team gave it a 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Addition of Nivolumab to Chemotherapy in Treatment of Soft Tissue Sarcoma

2020. "Testing the Addition of Nivolumab to Chemotherapy in Treatment of Soft Tissue Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04339738.

All > Angiosarcoma > Soft Tissue Sarcoma