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PD-1 Inhibitor

Regorafenib + Pembrolizumab for Colorectal Cancer

Phase 1 & 2
Waitlist Available
Led By Heinz-Josef Lenz, 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)
Must not have
Patients with a seizure disorder who require pharmacotherapy
Persistent proteinuria > 3.5 g/24 hours measured by urine protein-creatinine ratio from a random urine sample (>= grade 3, NCI-CTCAE version [v] 4.0)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 months after study entry
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial is testing a combination of regorafenib and pembrolizumab in patients with advanced colorectal cancer. Regorafenib directly attacks cancer cells, and pembrolizumab helps the immune system fight the 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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I take medication to control my seizures.
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My urine test shows high protein levels.
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I haven't had severe bleeding in the last 4 weeks.
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I haven't received any live vaccines in the last 30 days and won't during the trial.
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I have brain metastasis causing symptoms.
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I am not pregnant, breastfeeding, or planning to become pregnant.
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I am not receiving any cancer treatments other than regorafenib and pembrolizumab.
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My high blood pressure is hard to control even with multiple medications.
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I haven't had major surgery or a serious injury in the last 28 days.
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I have a history of bleeding disorders, regardless of severity.
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I do not have active hepatitis B.
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I am not on long-term steroids or immunosuppressants, nor have I taken them in the last 14 days.
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I have a wound, ulcer, or bone fracture that is not healing.
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I am not currently on, nor have I recently taken, any excluded medications.
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I have severe heart failure.
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I have taken regorafenib in the past.
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I need drainage for fluid in my chest or abdomen more than once a week.
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I have a blockage in my digestive tract.
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I have active symptoms of interstitial lung disease.
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I have tested positive for HIV, HTLV-1, hepatitis B, or hepatitis C.
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I do not have a severe infection right now.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
82%
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%
Large intestine perforation
1%
Oesophagitis
1%
Lung abscess
1%
embolism
1%
pancreatic carcinoma
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

Awards & Highlights

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.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Regorafenib and pembrolizumab are two treatments being studied for colorectal cancer. Regorafenib works by inhibiting multiple protein kinases involved in tumor growth, angiogenesis, and the tumor microenvironment, thereby slowing cancer progression. Pembrolizumab, on the other hand, is an immune checkpoint inhibitor that blocks the PD-1 receptor, enhancing the immune system's ability to recognize and destroy cancer cells. These mechanisms are important for colorectal cancer patients as they offer targeted approaches to control tumor growth and improve survival rates.
Regorafenib in the treatment of colorectal cancer.

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
944 Previous Clinical Trials
1,604,570 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,924 Previous Clinical Trials
41,017,876 Total Patients Enrolled
Heinz-Josef Lenz, MDPrincipal InvestigatorUniversity of Southern California
12 Previous Clinical Trials
818 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
~7 spots leftby Jun 2025