Your session is about to expire
← Back to Search
Checkpoint Inhibitor
Regorafenib + Immunotherapy for Colorectal Cancer
Phase 1
Waitlist Available
Led By Marwan G Fakih
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Microsatellite status should be performed per local standard of practice (e.g., immunohistochemistry [IHC] and/or polymerase chain reaction [PCR], or next-generation sequencing). Only participants with pMMR/MSS metastatic colorectal cancer (mCRC) are eligible
Histological or cytological confirmed advanced, metastatic, or progressive mismatch repair protein proficient (pMMR)/microsatellite stable (MSS) adenocarcinoma of colon or rectum
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post treatment
Awards & highlights
Study Summary
This trial is studying regorafenib in combination with ipilimumab and nivolumab to see if it can help to treat patients with colorectal cancer that has spread and is resistant to chemotherapy.
Who is the study for?
This trial is for adults with metastatic colorectal cancer that's stable at the microsatellite level and hasn't responded to chemotherapy. Participants should have a good performance status, acceptable organ function tests, measurable disease, and no prior treatment with the study drugs. They must not be pregnant or breastfeeding and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the combination of Regorafenib (a growth inhibitor), Ipilimumab, and Nivolumab (both immune system boosters) in patients whose colorectal cancer has spread and resisted chemotherapy. It aims to find the safest dose while observing how well these drugs work together against cancer.See study design
What are the potential side effects?
Possible side effects include fatigue, high blood pressure, diarrhea, skin reactions, liver enzyme changes, immune-related conditions like inflammation in organs or glands (thyroiditis), potential infections due to lowered immunity, and infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My colorectal cancer is not microsatellite unstable.
Select...
My colon or rectum cancer is advanced, spreading, and not responsive to certain DNA repair errors.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer's RAS and BRAF gene status is known.
Select...
I can swallow and absorb pills.
Select...
I can provide a recent sample of my tumor for the study.
Select...
I agree to use birth control during the study and for some months after.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended dose level of the combination
Secondary outcome measures
Duration of response
Objective response rate (ORR)
Overall survival
+1 moreOther outcome measures
Immune response
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 (regorafenib, nivolumab, ipilimumab)Experimental Treatment3 Interventions
Patients receive regorafenib PO QD on days 1-21, nivolumab IV over 30 minutes Q2W, and ipilimumab IV over 30 minutes Q6W. Cycles repeat every 28 day for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2620
Nivolumab
2014
Completed Phase 3
~4750
Regorafenib
2014
Completed Phase 2
~1580
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
569 Previous Clinical Trials
1,924,649 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,332 Total Patients Enrolled
Marwan G FakihPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
175 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had cancer before, but it's not skin cancer or certain in situ cancers, and I'm not currently undergoing treatment.I have brain metastases but am stable, not on high steroids, or my steroid dose is stable or decreasing.My colorectal cancer is MSI-H.I have previously been treated with regorafenib or immune checkpoint inhibitors.I have severe diarrhea or a major digestive disorder like Crohn's.My liver enzymes are within the allowed range for my cancer condition.I have not had a heart attack or unstable chest pain in the last 6 months.I haven't had cancer treatment within the last 14 days or 5 half-lives of the drug.My colorectal cancer is not microsatellite unstable.My condition worsened after treatment with specific medications.I don't have major side effects from previous treatments, except for anemia, hair loss, or skin changes.My colon or rectum cancer is advanced, spreading, and not responsive to certain DNA repair errors.I am fully active or restricted in physically strenuous activity but can do light work.I have a history of bleeding disorders, regardless of severity.I have not had severe bleeding in the last 28 days.I have an immune system disorder or am on high-dose steroids or other drugs that weaken my immune system.I am currently receiving treatment for a serious infection.My kidney function, measured by creatinine levels, is within the required range.I haven't had any blood clots or strokes in the last 3 months.My urine test shows high protein but less than 3.5 g/24 hr.I do not have irregular heartbeats that are uncontrolled.I have tested positive for hepatitis B or C.I have not received a live vaccine within the last 30 days.My cancer's RAS and BRAF gene status is known.I have been diagnosed with HIV.My blood pressure is often over 150/90 mmHg, even with treatment.I have not had major surgery or significant injury in the last 28 days.My tumor sample was taken within the last 6 months after my last cancer treatment.I have an autoimmune disease but it's either mild or well-controlled.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.My heart condition limits my physical activity.I can swallow and absorb pills.I have a history of lung scarring or fibrosis.I have had pneumonitis treated with steroids or have it now.I can provide a recent sample of my tumor for the study.I agree to use birth control during the study and for some months after.I have a wound, ulcer, or bone fracture that is not healing.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (regorafenib, nivolumab, ipilimumab)
Awards:
This trial has 1 awards, including:- 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.
What are the indications for Regorafenib?
"Regorafenib is a common treatment for unresectable melanoma, as well as squamous cell carcinoma and other high-risk forms of cancer with the potential for recurrence."
Answered by AI
Are there any limitations on the number of participants recruited for this clinical trial?
"Unfortunately, this trial is not accepting new candidates as of now. Initially posted on May 27th 2020 and last updated August 22nd 2022, other options are available with 1989 studies actively recruiting colorectal cancer patients while 809 trials require Regorafenib participants."
Answered by AI
Are there any previous experiments that have evaluated the effectiveness of Regorafenib?
"Currently, 809 medical trials are studying the efficacy and safety of Regorafenib with 91 studies in Phase 3. Although most of these experiments take place in Pittsburgh, Pennsylvania; 43504 other locations around the world have joined this research project."
Answered by AI
Is there an ongoing recruitment period for this research study?
"This medical experiment is no longer enrolling patients, with the initial posting on May 27th 2020 and last update occurring on August 22nd 2022. Fortunately there are numerous other studies that still need people to participate; 1989 trials are seeking individuals suffering from colorectal cancer while 809 experiments require participants for Regorafenib treatments."
Answered by AI
Has Regorafenib received official sanction from the Food and Drug Administration?
"Regorafenib's safety score is a 1 since this is still at the Phase I stage in terms of clinical trials. This indicates that there is limited data to support its efficacy and safety profile."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger