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Cancer Vaccine

Combination Immunotherapy for Small Bowel and Colorectal Cancer

Phase 2
Waitlist Available
Led By Julius Y Strauss, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status <= 2
Serum creatinine <= 1.5 x upper limit of normal (ULN) OR Measured or calculated creatinine clearance >= 40 mL/min for participant with creatinine levels > 1.5 X institutional ULN (GFR can also be used in place of creatinine or CrCl)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combination of immunotherapy drugs to see if it can shrink tumors in people with advanced small bowel and colorectal cancers.

Who is the study for?
Adults over 18 with advanced small bowel or colorectal cancer who've had at least two prior treatments (unless ineligible or declined standard treatment), can perform daily activities (ECOG <=2), and have functioning major organs. They must use effective contraception, understand the trial, and sign consent. People with HIV, Hep B/C are eligible if viral loads are undetectable.
What is being tested?
The trial is testing a combination of immunotherapy drugs: CV301 vaccine, M7824 (MSB0011359C), N-803 (Anktiva), and some will also receive NHS-IL12. The goal is to see if these drugs can shrink tumors in patients with advanced cancers when given as injections or infusions for up to one year.
What are the potential side effects?
Potential side effects may include typical immune-related reactions such as inflammation in various body parts, flu-like symptoms from the vaccines, injection site reactions, fatigue, possible changes in blood counts leading to increased infection risk or bleeding tendencies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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My kidney function, measured by creatinine or GFR, is within the required range.
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My cancer is in the small bowel or colon and has spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate (ORR) for Quadruple Therapy
Objective Response Rate (ORR) for Triple Therapy
Secondary study objectives
Duration of Response (DOR)
Number of Participants Hospitalized Due to Serious Adverse Events Attributed to Progressive Disease (PD)
Number of Participants With Grade 3, Grade 4, and/or Grade 5 Adverse Events Related to Quadruple Therapy
+3 more
Other study objectives
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Side effects data

From 2024 Phase 2 trial • 32 Patients • NCT04491955
100%
Injection site reaction
92%
Flu like symptoms
42%
Anemia
42%
Abdominal pain
42%
Aspartate aminotransferase increased
42%
Fatigue
42%
Rash acneiform
33%
Alanine aminotransferase increased
33%
Fever
33%
Pruritus
25%
Disease progression
25%
Alkaline phosphatase increased
25%
Dyspnea
25%
Urinary tract infection
17%
Back pain
17%
Dysuria
17%
Chills
17%
Constipation
17%
Proteinuria
17%
Epistaxis
17%
Hyperglycemia
17%
Nausea
17%
Pain in extremity
17%
Vomiting
8%
General disorders and administration site conditions - Other, specify
8%
Lung infection
8%
Hematuria
8%
Lethargy
8%
Cardiac troponin I increased
8%
Sepsis
8%
Adrenal insufficiency
8%
Edema face
8%
Blood bilirubin increased
8%
Cough
8%
Dry skin
8%
Gastric ulcer
8%
General disorders and administration site conditions - Other, Mucosal bleeding
8%
Hot flashes
8%
Hypokalemia
8%
Hypophosphatemia
8%
Infusion related reaction
8%
Mucositis oral
8%
Myalgia
8%
Oral hemorrhage
8%
Papulopustular rash
8%
Paresthesia
8%
Skin hyperpigmentation
8%
Thrush
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241)
Cohort 2, Arm 2a, Dose Level (DL) DL2, Quad Therapy Dose Escalation
Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation
Cohort 2, Arm 2b Dose Level (DL)2, Quad Therapy Fixed Dose

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: 3/Arm 2BExperimental Treatment4 Interventions
CEA/ MUC1 Vaccines + M7824 + N-803 + NHSIL12 (Quadruple Therapy); fixed dose of NHS-IL12.
Group II: 2/Arm 2AExperimental Treatment4 Interventions
CEA/ MUC1 Vaccines + M7824 + N-803 + NHSIL12 (Quadruple Therapy); dose escalation of NHS-IL12.
Group III: 1/Arm 1Experimental Treatment3 Interventions
CEA/ MUC1 Vaccines + M7824 + N-803 (Triple Therapy).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NHS-IL12
2020
Completed Phase 2
~40
CV301
2016
Completed Phase 2
~100
N-803
2021
Completed Phase 2
~80
MSB0011359C
2016
Completed Phase 2
~750

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,916 Previous Clinical Trials
41,011,795 Total Patients Enrolled
Julius Y Strauss, M.D.Principal InvestigatorNational Cancer Institute (NCI)
5 Previous Clinical Trials
256 Total Patients Enrolled
~6 spots leftby Nov 2025
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