Your session is about to expire
← Back to Search
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 belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My colorectal cancer is advanced, and I can't tolerate standard treatments.
Select...
I agree to use contraception for 31 weeks after my last dose of the study drug.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 months after study entry
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months after study entry
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 • NCT0202460782%
Diarrhoea
76%
Nausea
71%
Fatigue
57%
Vomiting
53%
Abdominal pain
30%
Neuropathy peripheral
27%
Dyspnoea
25%
Anaemia
23%
Neutrophil count decreased
23%
Constipation
22%
Weight decreased
21%
Hypokalaemia
20%
Oedema peripheral
18%
Dehydration
17%
Cough
17%
Neutropenia
17%
Pyrexia
17%
Peripheral sensory neuropathy
16%
Thrombocytopenia
15%
Platelet count decreased
15%
Back pain
13%
Mucosal inflammation
13%
Temperature intolerance
13%
Dysgeusia
13%
Chromaturia
12%
White blood cell count decreased
12%
Urinary tract infection
11%
Dizziness
11%
Depression
10%
Hyponatraemia
10%
Stomatitis
10%
Ascites
10%
Dysphagia
10%
Anxiety
9%
Headache
9%
Abdominal distension
9%
Insomnia
8%
Arthralgia
8%
Asthenia
8%
Pain in extremity
8%
Alopecia
7%
Urine ketone body present
7%
Blood alkaline phosphatase increased
7%
Pulmonary embolism
6%
Lymphopenia
6%
Leukopenia
6%
Blood bilirubin increased
6%
Dyspepsia
5%
Sepsis
5%
Palmar-plantar erythrodysaesthesia syndrome
5%
Hypertension
5%
Urine leukocyte esterase positive
5%
Abdominal pain upper
5%
Gastrooesophageal reflux disease
5%
Proteinuria
5%
Rash
4%
Flatulence
4%
Chills
3%
Dry mouth
3%
Myalgia
3%
Epistaxis
3%
Muscle spasms
2%
Pneumonia
2%
pelvic fracture
2%
Haematemesis
2%
Disease progression
2%
Pleural effusion
2%
Confusional state
2%
Mental status changes
2%
malignant neoplasm progression
1%
pancreatic carcinoma
1%
Lung abscess
1%
Large intestine perforation
1%
Oesophagitis
1%
embolism
1%
fall
1%
Death
1%
Haemorrhage intranial
1%
Atrial fibrillation
1%
Colitis
1%
Enterocutaneous fistula
1%
Gastrointestinal haemorrhage
1%
Upper gastrointestinal haemorrhage
1%
Chest pain
1%
somnolence
1%
syncope
1%
Febrile neutropenia
1%
Acute kidney injury
1%
Acute respiratory failure
1%
Hypoxia
1%
Pneumonia aspiration
1%
Clostridium difficile colitis
1%
Influenza
1%
Perirectal abscess
1%
Salmonella sepsis
1%
Septic shock
1%
hip fracture
1%
deep vein thrombosis
1%
haematoma
1%
pelvic venous thrombosis
1%
Cholangitis
1%
Ischaemic cerebral infarction
1%
Hyperglycaemia
1%
subdural haematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Napabucasin Plus FOLFOX6
Napabucasin Plus FOLFOX6 Plus Bevacizumab
Napabucasin Plus FOLFIRI Plus Bevacizumab
Napabucasin Plus Regorafenib
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
906 Previous Clinical Trials
1,595,974 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,296 Total Patients Enrolled
Afsaneh Barzi, MDPrincipal InvestigatorUniversity of Southern California
4 Previous Clinical Trials
68 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I take medication to control my seizures.I haven't had severe bleeding in the last 4 weeks.I haven't received any live vaccines in the last 30 days and won't during the trial.I am taking steroids for reasons not related to immune system reactions.I am fully active or restricted in physically strenuous activity but can do light work.I have brain metastasis causing symptoms.I am not pregnant, breastfeeding, or planning to become pregnant.I am not receiving any cancer treatments other than regorafenib and pembrolizumab.I haven't had major surgery or a serious injury in the last 28 days.My colorectal cancer is advanced, and I can't tolerate standard treatments.I can take pills by mouth.My high blood pressure is hard to control even with multiple medications.I had a heart attack or unstable angina and received a stent or angioplasty within the last 6 months.I haven't had major surgery or a serious injury in the last 28 days.I have a history of bleeding disorders, regardless of severity.I agree to use contraception for 31 weeks after my last dose of the study drug.I do not have active hepatitis B.I am not on long-term steroids or immunosuppressants, nor have I taken them in the last 14 days.My blood clotting tests are within normal limits, or I am on stable blood thinners.I agree to use birth control for 23 weeks after my last dose if I can become pregnant.My urine test shows high protein levels.I am on blood thinners for treatment, not just for prevention.I have a wound, ulcer, or bone fracture that is not healing.I am not currently on, nor have I recently taken, any excluded medications.I have severe heart failure.I have taken regorafenib in the past.I need drainage for fluid in my chest or abdomen more than once a week.I have a blockage in my digestive tract.I haven't had cancer treatment except immune therapy in the last 2 weeks.I have active symptoms of interstitial lung disease.I have tested positive for HIV, HTLV-1, hepatitis B, or hepatitis C.I do not have a severe infection right now.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab, regorafenib)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger