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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)

Must not have

Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy or immunosuppressive therapy within 7 days prior to the first dose of trial treatment

Active autoimmune disease requiring systemic treatment in past 2 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an immune system disorder or have been on steroids or immune-suppressing drugs recently.

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I have not needed treatment for an autoimmune disease in the last 2 years.

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I have had brain function issues in the last 6 months.

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My cancer has spread to my brain or its coverings.

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I have fluid buildup in my abdomen or around my lungs that causes symptoms.

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I am currently on medication for an infection.

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I have been diagnosed with HIV.

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I have had pneumonitis treated with steroids or have it now.

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I do not have any serious illnesses that are not under control.

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I have had an organ or bone marrow transplant.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Neoplasms

Secondary study objectives

Median Relapse-free survival (RFS) per RECIST 1.1

Objective response rate (ORR)

Pathologic response rate

+4 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

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 (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

Vactosertib

2017

Completed Phase 1

~20

Hepatectomy

2020

Completed Phase 2

~2040