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Angiogenesis Inhibitor

Nab-Paclitaxel + Bevacizumab for Advanced Cancer

Phase 1
Waitlist Available
Led By Matthew S Block
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Endometrial cancer expansion cohort only: Histologic proof of endometrial cancer including endometrioid, serous, clear cell, mucinous, undifferentiated, mixed, and carcinosarcoma histologies
At least one prior line of cytotoxic chemotherapy must also have contained bevacizumab
Must not have
History of inflammatory bowel disease requiring ongoing therapy
Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection requiring systemic treatment, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations (e.g., drug addiction) that would limit compliance with study requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying the side effects and best dose of the combination of nab-paclitaxel and bevacizumab in treating patients with stage IV melanoma or other cancers of the cervix, endometrium, ovary, fallopian tube, or peritoneal cavity.

Who is the study for?
This trial is for adults with stage IV melanoma or gynecological cancers that can't be surgically removed. Participants must have had 1-4 prior chemotherapy treatments, including a taxane and platinum agent, and be resistant to platinum if they've had 1-2 chemo lines. They should not have received certain therapies recently and must not have other severe diseases or conditions that could affect the study.
What is being tested?
The trial tests nab-paclitaxel combined with bevacizumab versus nab-paclitaxel alone in patients with advanced melanoma or gynecological cancers. It aims to find the safest doses and see if adding bevacizumab improves outcomes by inhibiting blood vessel growth necessary for tumor survival.
What are the potential side effects?
Potential side effects include reactions at the infusion site, fatigue, nausea, low blood cell counts increasing infection risk, nerve damage causing numbness or tingling sensations (neuropathy), high blood pressure due to bevacizumab's effect on blood vessels, and increased risk of bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My endometrial cancer has been confirmed by tissue analysis.
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I have received chemotherapy that included bevacizumab.
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I have had at least one treatment for cancer that has spread.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My nerve damage symptoms are mild or not present.
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I have stage IV melanoma that cannot be removed with surgery.
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My cancer is a type of endometrial cancer.
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I have ovarian cancer and received specific drugs in my treatment.
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I do not have any nerve damage in my hands or feet.
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I've had 1-3 rounds of specific cancer treatments, not including hormone therapy.
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My first cancer treatment included a taxane, platinum drug, and immune checkpoint inhibitor.
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I've had 2-3 treatments including a taxane, a platinum drug, and an immune therapy.
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I have previously received chemotherapy that included both a taxane and a platinum agent.
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My cancer did not respond to platinum-based chemotherapy after 1 or 2 treatments.
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I have had 1-4 rounds of chemotherapy.
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My cancer is a type of gynecologic cancer.
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I am 18 years old or older.
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My melanoma can be measured by scans and is at least 1 cm large.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently being treated for inflammatory bowel disease.
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
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I had severe bowel side effects from immune therapy within the last 3 months.
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I have not had major surgery in the last 6 weeks and do not plan to have any during the study.
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I have had 3 or fewer cancer treatments in the last 2 years.
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I received ipilimumab treatment for melanoma less than 6 months ago.
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I still have side effects from my last chemotherapy that haven't gone away.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum tolerated dose (MTD
Secondary study objectives
Incidence of adverse events (soft tissue expansion cohort)
Overall survival (OS)
Progression-free survival (PFS)
+1 more

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358
33%
Infusion Related Reaction
33%
Alanine aminotransferase increased
33%
Aspartate aminotransferase increased
33%
Neutrophil count decreased
17%
Sinusitis
17%
Tumor Lysis Syndrome
17%
Interoperative Hemorrhage
17%
Platelet count decreased
17%
Febrile neutropenia
17%
Infusion related reaction
17%
Upper respiratory infection
17%
Otitis externa
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1, Dose 1 (400 mg Entospletinib Daily)
Phase 2 and MTD (800 mg Entospletinib Daily)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (AB-complex)Experimental Treatment4 Interventions
Patients receive nab-paclitaxel/bevacizumab-complex IV over 30-60 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patient may receive paclitaxel if supply of nab-paclitaxel is exhausted.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5540
Nab-paclitaxel
2014
Completed Phase 3
~1950

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,326 Previous Clinical Trials
3,059,439 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,906 Previous Clinical Trials
41,011,985 Total Patients Enrolled
5 Trials studying Cutaneous Melanoma
146 Patients Enrolled for Cutaneous Melanoma
Matthew S BlockPrincipal InvestigatorMayo Clinic in Rochester
4 Previous Clinical Trials
130 Total Patients Enrolled

Media Library

Bevacizumab (Angiogenesis Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02020707 — Phase 1
Cutaneous Melanoma Research Study Groups: Treatment (AB-complex)
Cutaneous Melanoma Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT02020707 — Phase 1
Bevacizumab (Angiogenesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02020707 — Phase 1
Cutaneous Melanoma Patient Testimony for trial: Trial Name: NCT02020707 — Phase 1
~4 spots leftby Nov 2025