← Back to Search

PD-1 Inhibitor

Pembrolizumab + Dendritic Cell Therapy for Colorectal Cancer

Phase 2

Waitlist Available

Led By Sarbajit Mukherjee

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

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

Must have

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Recurrent and/or metastatic unresectable microsatellite stable (MSS) colorectal cancer

Must not have

Has an active infection requiring systemic therapy

Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected) infection. Note: no testing for hepatitis B and hepatitis C is required

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether pembrolizumab and dendritic cell-based treatment can shrink tumors in patients with colorectal cancer that has not responded to other treatments.

Who is the study for?

This trial is for adults with colorectal cancer that hasn't improved with standard treatments. They must have not used PD-1/PD-L1/PD-L2 inhibitors before, have at least two measurable tumors, and be in good physical condition (ECOG 0-1). Participants need functioning major organs and agree to use effective birth control. Those with severe allergies to pembrolizumab, active lung disease, ongoing immunosuppression, or recent other cancer treatments are excluded.

What is being tested?

The trial tests a combination of pembrolizumab (an immune checkpoint inhibitor) and dendritic cell-based therapy made from the patient's own blood cells. The goal is to see if this combo can shrink colorectal tumors by enhancing the body's immune response against cancer.

What are the potential side effects?

Potential side effects include reactions related to the immune system such as inflammation in various organs, fatigue, flu-like symptoms, skin reactions, digestive issues like diarrhea or constipation, and an increased risk of infections due to immune system activation.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am fully active or can carry out light work.

Select...

My colorectal cancer cannot be removed by surgery and is not microsatellite unstable.

Select...

I have at least 2 tumors that can be measured and one can be biopsied.

Select...

My kidney function, measured by creatinine clearance, is sufficient.

Select...

I am 18 years old or older.

Select...

I have not received PD-1/PD-L1/PD-L2 treatments.

Exclusion Criteria

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

Select...

I am currently being treated for an infection.

Select...

I have a known history of hepatitis B or active hepatitis C.

Select...

I have an active autoimmune disease or a history of transplantation.

Select...

I am on low-dose steroids or other immunosuppressants.

Select...

I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

Select...

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Select...

I have been treated with drugs targeting immune checkpoints.

Select...

I have or had lung inflammation that needed steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Incidence of toxicities and adverse events

Objective response rate

Overall survival

+1 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

Localised oedema

Ear pain

Urinary tract infection

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Pneumonia aspiration

Sepsis

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Clostridium difficile colitis

Cardiac arrest

Systemic infection

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 (pembrolizumab, autologous dendritic cells)Experimental Treatment3 Interventions

Patients receive pembrolizumab IV on days 8, 29, 50, and 71, and autologous dendritic cells intratumorally on days 1 and 8 in the absence of disease progression or unacceptable toxicity. Patients may also receive an autologous dendritic cells intratumorally on day 50.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1150

Therapeutic Autologous Dendritic Cells

2017

Completed Phase 2

~10