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PD-1 Inhibitor

Regorafenib + Pembrolizumab for Colorectal Cancer

Phase 1 & 2
Waitlist Available
Led By Afsaneh Barzi, MD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Patients with histologically or cytologically confirmed advanced or metastatic colorectal cancer who had failed or are intolerant of oxaliplatin, irinotecan, and fluorouracil (5-FU)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 months after study entry
Awards & highlights

Study Summary

This trial is testing regorafenib given with pembrolizumab to see if it is more effective than regorafenib given alone for patients with metastatic colorectal cancer.

Who is the study for?
This trial is for adults with advanced or metastatic colorectal cancer who have not responded to standard treatments. They must be able to take oral medication, have certain blood and liver function levels within specific ranges, and agree to use contraception during and after the trial. Those with severe heart conditions, uncontrolled hypertension, active infections or autoimmune diseases are excluded.Check my eligibility
What is being tested?
The study is testing the combination of two drugs: Regorafenib (a chemotherapy drug) and Pembrolizumab (an immunotherapy monoclonal antibody). The goal is to find out if this combo is more effective in stopping the growth or spread of colorectal cancer cells compared to current treatments.See study design
What are the potential side effects?
Possible side effects include fatigue, skin reactions, diarrhea, increased blood pressure from Regorafenib; immune-related issues like inflammation in organs or infusion reactions from Pembrolizumab. Each patient's experience may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My colorectal cancer is advanced, and I can't tolerate standard treatments.
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I agree to use contraception for 31 weeks after my last dose of the study drug.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months after study entry
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months after study entry 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 (DLTs) (Phase I)
Overall survival (OS)
Progression-free survival (PFS) (Phase II)

Side effects data

From 2019 Phase 1 & 2 trial • 495 Patients • NCT02024607
90%
Diarrhoea
78%
Nausea
61%
Vomiting
61%
Fatigue
54%
Abdominal pain
37%
Neutropenia
32%
Neuropathy peripheral
27%
Constipation
24%
Dehydration
24%
Weight decreased
22%
Peripheral sensory neuropathy
22%
Anaemia
20%
Cough
20%
Hypokalaemia
20%
Thrombocytopenia
17%
Back pain
17%
Urine ketone body present
17%
Chills
17%
Proteinuria
17%
Epistaxis
15%
Dyspnoea
15%
Headache
15%
Urine leukocyte esterase positive
15%
Dyspepsia
15%
Mucosal inflammation
15%
Pyrexia
15%
Hypertension
12%
Stomatitis
12%
Leukopenia
12%
Blood alkaline phosphatase increased
12%
Gastrooesophageal reflux disease
12%
Lymphopenia
12%
Dysgeusia
12%
Dizziness
12%
Insomnia
12%
Anxiety
10%
Neutrophil count decreased
10%
Blood bilirubin increased
10%
Temperature intolerance
10%
Pain in extremity
10%
Alopecia
10%
Pulmonary embolism
7%
Dry mouth
7%
Ascites
7%
Arthralgia
7%
Myalgia
7%
Platelet count decreased
7%
Small intestinal obstruction
7%
White blood cell count decreased
7%
Abdominal pain upper
7%
Asthenia
7%
Muscle spasms
7%
Chromaturia
7%
Urinary tract infection
7%
Depression
5%
Hyponatraemia
5%
Abdominal distension
5%
Flatulence
5%
Oedema peripheral
5%
Rash
2%
Enteritis
2%
Colitis
2%
Non-cardiac chest pain
2%
Respiratory failure
2%
Clostridium difficile colitis
2%
deep vein thrombosis
2%
Dysphagia
2%
Palmar-plantar erythrodysaesthesia syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Napabucasin Plus FOLFOX6 Plus Bevacizumab
Napabucasin Plus Regorafenib
Napabucasin Plus FOLFOX6
Napabucasin Plus FOLFIRI Plus Bevacizumab
Napabucasin Plus FOLFIRI
Napabucasin Plus Irinotecan
Napabucasin Plus CAPOX

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, regorafenib)Experimental Treatment2 Interventions
Participants receive pembrolizumab IV over 30 minutes on day 1 and regorafenib PO QD on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Regorafenib
FDA approved

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
899 Previous Clinical Trials
1,595,228 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,571 Total Patients Enrolled
Afsaneh Barzi, MDPrincipal InvestigatorUniversity of Southern California
4 Previous Clinical Trials
68 Total Patients Enrolled

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03657641 — Phase 1 & 2
Colorectal Cancer Research Study Groups: Treatment (pembrolizumab, regorafenib)
Colorectal Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03657641 — Phase 1 & 2
Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03657641 — Phase 1 & 2

Frequently Asked Questions

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

Are there still opportunities to join this experiment?

"Records provided by clinicaltrials.gov indicate that this specific medical trial is not presently enrolling participants, though it was initially posted on June 21st 2019 and last updated August 5th 2022. Fortunately, there are 2090 other active trials which may require patient participation."

Answered by AI

To what medical maladies is Regorafenib commonly prescribed?

"Regorafenib can be employed to treat melanoma that is not possible to surgically remove, microsatellite instability high tumours, and those with a precarious tendency towards relapse."

Answered by AI

What other investigations have been conducted pertaining to Regorafenib?

"Currently, there are 1,012 studies associated with Regorafenib; 127 of them have entered Phase 3. These trials primarily take place in Rochester, Minnesota although they can be found at 36453 sites around the world."

Answered by AI

In what capacity is this clinical trial being implemented?

"Potential participants can join this medical trial at City of Hope in Duarte, Moffitt Cancer Center in Tampa, and Hoag Memorial Hospital in Newport Beach. Additionally, there are 4 other locations that are recruiting patients for the study."

Answered by AI

How many individuals are enrolled in this trial?

"At the present time, this trial is no longer recruiting participants. As per records on clinicaltrials.gov, the project was first posted in June 21st 2019 and most recently updated on August 5th 2022. For those looking for alternative studies with metastatic colorectal cancer (crc), there are currently 1078 trials that need volunteers; 1012 Regorafenib related medical investigations are also actively seeking subjects as well."

Answered by AI
~2 spots leftby Jun 2024