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Monoclonal Antibodies

Immunotherapy + Targeted Therapy for Metastatic Colorectal Cancer

Phase 2

Recruiting

Led By Chloe Atreya, MD, Ph.D.

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically confirmed CRC with liver metastases

Locally confirmed MSS or pMMR Colorectal cancer (CRC)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing a combination of immunotherapy and targeted therapy as a treatment for colorectal cancer that has spread to the liver and can be removed by surgery.

Who is the study for?

This trial is for adults with colorectal cancer that has spread to the liver and can be surgically removed. Participants must have had oxaliplatin-based chemo, be able to undergo a liver biopsy and surgery, use contraception if of childbearing potential, and not have certain health conditions or recent treatments that could affect the trial.Check my eligibility

What is being tested?

The study tests pembrolizumab (an immunotherapy drug) combined with vactosertib after standard chemotherapy but before liver surgery in patients with colorectal cancer. The goal is to shrink the cancer before removal and reduce recurrence risk after surgery.See study design

What are the potential side effects?

Pembrolizumab may cause immune-related side effects like inflammation in organs, fatigue, skin reactions, hormonal gland problems (like thyroid), infusion reactions; while vactosertib might lead to issues such as nausea, diarrhea, blood count changes.

Eligibility Criteria

Inclusion Criteria

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

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My colorectal cancer has spread to my liver.

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My colorectal cancer is not microsatellite instability-high (MSI-H).

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I am 18 years old or older.

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I have been treated with oxaliplatin-based chemotherapy before.

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I have received oxaliplatin-based chemotherapy before.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

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

Neoplasms

Secondary outcome measures

Median Relapse-free survival (RFS) per RECIST 1.1

Objective response rate (ORR)

Pathologic response rate

+4 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (vactosertib, pembrolizumab, surgery)Experimental Treatment3 Interventions

Neoadjuvant pembrolizumab will be administered at a fixed dose of 200 mg (IV) for 1 cycle plus 200 mg vactosertib (PO QD, 5 days per week x 2 weeks). Adjuvant pembrolizumab (400 mg IV) + vactosertib (200 mg PO QD Cycle 1, 5 days per week, Cycles 2 and beyond (200 mg BID, 5 days per week) will be administered for up to eight 6-week cycles

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hepatectomy

2020

Completed Phase 2

~2040

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,237,536 Total Patients Enrolled

Chloe Atreya, MD, PhDLead Sponsor

Merck Sharp & Dohme LLCIndustry Sponsor

3,888 Previous Clinical Trials

5,055,038 Total Patients Enrolled

Frequently Asked Questions

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

What is the current participant count for this clinical research?

"Affirmative. As indicated on clinicaltrials.gov, this trial is currently in the process of recruiting participants; having been initially posted on July 22nd 2019 and most recently updated April 26th 2021. 19 individuals are to be enlisted from one medical facility."

Answered by AI

What are the fundamental goals of this clinical trial?

"This clinical trial seeks to measure the proportion of patients that experienced a greater than 2-fold increase in tumor infiltrating CD3+ T cells per unit area. Secondary objectives include collecting and evaluating objective response rate, incidence of treatment-related adverse events, and partial response rate for those receiving pembrolizumab over approximately two years."

Answered by AI

Are there any current openings to enlist in this clinical experiment?

"Confirmed, this clinical trial is open to volunteers. The study was first uploaded onto clinicaltrials.gov on July 22nd 2019 and the details were revised as recently as April 26th 2022."

Answered by AI

Has Pembrolizumab been examined in any other research studies?

"At present, there is a wealth of clinical trials involving Pembrolizumab; specifically, 971 studies are currently underway with 122 being Phase 3. The most noteworthy concentration lies in Houston, Texas but these experiments span over 35 thousand different sites worldwide."

Answered by AI

What hazards should patients be aware of when taking Pembrolizumab?

"Our team at Power scored Pembrolizumab's safety a 2. This is because the clinical trial phase indicates that although there is data affirming its security, it lacks evidence for efficacy."

Answered by AI

What pathologies have been alleviated through the use of Pembrolizumab?

"Pembrolizumab is frequently utilized to treat metastatic neoplasms and other medical issues such as cutaneous melanoma, MSH-positive disease progression after chemotherapy, etc."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Preoperative Immunotherapy (Pembrolizumab) for Patients With Colorectal Cancer and Resectable Hepatic Metastases

Chloe Atreya, MD, PhD 2019. "Preoperative Immunotherapy (Pembrolizumab) for Patients With Colorectal Cancer and Resectable Hepatic Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03844750.

All > Lynch Syndrome > Colorectal Cancer