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Angiogenesis Inhibitor

Pembrolizumab + Trebananib for Advanced Cancer

Phase 1
Waitlist Available
Led By Osama Rahma, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be ≥ 18 years of age on day of signing informed consent
In dose escalation (Phase I), patients must have histologically or cytologically confirmed metastatic disease from any solid tumor that is incurable and fulfills specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a combination of drugs to see if they are effective in treating advanced solid tumors.

Who is the study for?
Adults with advanced solid tumors, specifically melanoma, ovarian, renal, or colorectal cancer. Participants must have tried certain previous treatments (like VEGF TKI for renal cell carcinoma and platinum therapy for ovarian cancer), be willing to provide tissue samples, and meet specific health criteria including organ function tests. Women of childbearing potential and men must agree to use contraception.Check my eligibility
What is being tested?
The trial is testing a combination of Pembrolizumab (an immunotherapy drug) and AMG386 (a drug targeting blood vessel growth in tumors) as a treatment for various advanced cancers. It aims to see how well these drugs work together against the disease.See study design
What are the potential side effects?
Possible side effects include allergic reactions similar to those from other proteins produced by bacteria or monoclonal antibodies like pembrolizumab. There may also be risks associated with immune system suppression leading to infections or complications related to existing conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have an incurable metastatic solid tumor confirmed by tests.
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I can carry out all my usual activities without help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
Dose Limiting Toxicity
Secondary outcome measures
Objective Response Rate
Overall Survival
Progression Free Survival

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

5Treatment groups
Experimental Treatment
Group I: Pembrolizumab + Trebananib (Renal Cell Carcinoma)Experimental Treatment2 Interventions
Part 2 Dose Expansion
Group II: Pembrolizumab + Trebananib (Ovarian)Experimental Treatment2 Interventions
Part 2 Dose Expansion
Group III: Pembrolizumab + Trebananib (Melanoma)Experimental Treatment2 Interventions
Part 2 Dose Expansion
Group IV: Pembrolizumab + Trebananib (Colorectal)Experimental Treatment2 Interventions
Part 2 Dose Expansion
Group V: Pembrolizumab + TrebananibExperimental Treatment2 Interventions
Part 1 Standard 3+3 Dose Escalation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950
Trebananib
2012
Completed Phase 2
~380

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,071 Previous Clinical Trials
340,304 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,672 Total Patients Enrolled
AmgenIndustry Sponsor
1,355 Previous Clinical Trials
1,384,011 Total Patients Enrolled

Media Library

AMG386 (Angiogenesis Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03239145 — Phase 1
Solid Tumors Research Study Groups: Pembrolizumab + Trebananib (Melanoma), Pembrolizumab + Trebananib (Renal Cell Carcinoma), Pembrolizumab + Trebananib (Colorectal), Pembrolizumab + Trebananib (Ovarian), Pembrolizumab + Trebananib
Solid Tumors Clinical Trial 2023: AMG386 Highlights & Side Effects. Trial Name: NCT03239145 — Phase 1
AMG386 (Angiogenesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03239145 — Phase 1

Frequently Asked Questions

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

What medical applications is Pembrolizumab typically employed for?

"Pembrolizumab is a powerful medication usually used to battle malignant neoplasms. It is also commonly taken as an intervention for unresectable melanoma, microsatellite instability high and cases where chemotherapy has failed or caused progression of the illness."

Answered by AI

Does this medical trial currently have openings for participants?

"As of now, this clinical trial is not accepting any more participants. It was first listed on August 31st 2017 and the most recent edit occured March 22nd 2022. However, if you are seeking to join other studies, there are 2502 trials currently enrolling patients with solid tumors and 961 for Pembrolizumab specifically."

Answered by AI

How many participants have joined the research endeavor thus far?

"As of March 22nd 2022, enrollment in this trial has ceased. It was initially advertised on August 31st 2017 and underwent its most recent edit at the above date. For those looking for alternative studies, there are 2502 admitting participants with solid tumors or advanced cases thereof as well as 961 trials offering Pembrolizumab to potential enrollees."

Answered by AI

Are there any other trials involving Pembrolizumab that have been conducted?

"Currently, there are 961 clinical trials exploring the use of Pembrolizumab; 122 of these studies have advanced to their third phase. While a majority of them are located in Houston, Texas, this medication is being tested at 35 731 sites across the world."

Answered by AI

How has Pembrolizumab demonstrated its efficacy in terms of patient safety?

"The safety of Pembrolizumab is rated at 1 on our scale because it is only in Phase 1 and thus has limited clinical data to support its efficacy or security."

Answered by AI
~8 spots leftby Mar 2025