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Cancer Vaccine

Combination Immunotherapy for Small Bowel and Colorectal Cancer

Q: What is the capacity of enrollment for this clinical trial?

Affirmative. Information on clinicaltrials.gov reveals that the study, which was initially posted on September 22nd 2020, is actively recruiting individuals for participation. Approximately 80 participants must be recruited from a single medical centre.

Q: Has there ever been a similar trial conducted in the past?

At the present moment, 20 trials for CV301 are currently underway in 332 cities and one nation. This drug was first trialed by ImmunityBio Inc. back in 2014 with 596 participants; since then 12 clinical studies have been finalized.

Q: Have any other tests been conducted to assess the efficacy of CV301?

At present, 20 active trials are underway to analyze CV301 with 3 in the third phase of clinical studies. A majority of these tests are located in Ann Arbor, <a href="https://www.withpower.com/clinical-trials/michigan">Michigan</a> however there is a total of 508 sites conducting research for this medication.

Q: Is enrollment for this experiment ongoing at the present moment?

The clinicaltrials.gov website suggests that this research protocol is still actively seeking patient involvement, with first postings on September 22nd 2020 and a recent edit done on November 17th 2022.

Q: How would you rate the potential hazard of CV301 for patients?

Our experts at Power rate the safety of CV301 as a 2 due to the absence of clinical data that supports its efficacy, despite some evidence pointing towards this drug's security.

Q: What aims are researchers striving to achieve with this clinical experiment?

This clinical trial, spanning roughly a year's time period, is primarily measuring overall response rate (ORR) for the Triple Therapy. Secondary outcomes encompass Hospitalization Due to PD AEs, Overall Survival and Safety of Quadruple Therapy respectively defined as ratio of participants that are hospitalized due to adverse events attributed to disease progression; assessment of survival per treatment assignment; evaluation of safety combination involving CV301, N-803, M7824 and NHS-IL12 in subjects with advanced small bowel and colorectal cancers.

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

Study 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.Check my eligibility

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.See study design

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.

Select...

My cancer can be measured by tests.

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My cancer is in the small bowel or colon and has spread.

Select...

My liver enzymes are within the required limits.

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I have undergone two rounds of systemic therapy or am unable to receive/declined standard treatment.

Select...

I have HIV or Hepatitis with undetectable viral loads and stable health.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR) for Quadruple Therapy

Objective Response Rate (ORR) for Triple Therapy

Secondary outcome measures

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 outcome measures

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 2021 Phase 2 trial • 43 Patients • NCT03628716

42%

Fatigue

32%

Decreased appetite

26%

Fall

21%

Diarrhoea

21%

Anaemia

16%

Lipase increased

16%

Hypotension

16%

Amylase increased

16%

Acute kidney injury

16%

Chills

16%

Adominal pain

16%

Hyponatraemia

11%

Weight decreased

11%

Confusional state

11%

Injection site pain

11%

Pyrexia

11%

Injection site swelling

11%

Constipation

11%

Vomiting

11%

Arthralgia

11%

Rhinorrhoea

11%

Headache

11%

Dehydration

11%

Insomnia

11%

Depression

11%

Muscular weaness

Abdominal pain

Weight increased

Urine odour abnormal

Clavicle fracture

Urinary retention

Hyperthyroidism

Cancer pain

Rash maculo-papular

Abnormal dreams

Presyncope

Aspartate aminotransferase increased

Troponin I increased

Hypothyroidism

Hyperhidrosis

Pruritus

Large intestinal obstruction

Urinary tract infection

Delirium

Cardiac arrest

Injection site erythema

Injection site reaction

Chest discomfort

Injection site irritation

Injection site warmth

Nodule

Nausea

Flatulence

Gastroesophageal reflux disease

Back pain

Flank pain

Groin pain

Musculoskeletal pain

Neck pain

Trigger finger

Hyperuricaemia

Hypomagnesaemia

Metabolic acidosis

Conjunctivitis

Influenza

Dizziness

Anxiety

Infusion related reaction

Chromaturia

Cystitis noninfective

Dysuria

Fluid overload

Hypoxia

Squamous cell carcinoma of skin

Pleural effusion

Hypercalcaemia

Hypophosphataemia

Sciatica

Muscle strain

Blood creatinine increased

Carbon dioxide decreased

Activated partial thromboplastin time prolonged

Infusion site uriticaria

Injection site inflammation

Abdominal discomfort

Dyspnoea

Dyspnoea exertional

Flushing

Haematuria

100%

80%

60%

40%

20%

Study treatment Arm

CV301 + Atezolizumab (Cohort 1)

CV301 + Atezolizumab (Cohort 2)

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

CV301

2016

Completed Phase 2

~70

N-803

2021

Completed Phase 2

~30

MSB0011359C

2016

Completed Phase 1

~720

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,646 Previous Clinical Trials

40,930,995 Total Patients Enrolled

Julius Y Strauss, M.D.Principal InvestigatorNational Cancer Institute (NCI)

5 Previous Clinical Trials

256 Total Patients Enrolled

Frequently Asked Questions

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

What is the capacity of enrollment for this clinical trial?

"Affirmative. Information on clinicaltrials.gov reveals that the study, which was initially posted on September 22nd 2020, is actively recruiting individuals for participation. Approximately 80 participants must be recruited from a single medical centre."

Answered by AI

Has there ever been a similar trial conducted in the past?

"At the present moment, 20 trials for CV301 are currently underway in 332 cities and one nation. This drug was first trialed by ImmunityBio Inc. back in 2014 with 596 participants; since then 12 clinical studies have been finalized."

Answered by AI

Have any other tests been conducted to assess the efficacy of CV301?

"At present, 20 active trials are underway to analyze CV301 with 3 in the third phase of clinical studies. A majority of these tests are located in Ann Arbor, Michigan however there is a total of 508 sites conducting research for this medication."

Answered by AI

Is enrollment for this experiment ongoing at the present moment?

"The clinicaltrials.gov website suggests that this research protocol is still actively seeking patient involvement, with first postings on September 22nd 2020 and a recent edit done on November 17th 2022."

Answered by AI

How would you rate the potential hazard of CV301 for patients?

"Our experts at Power rate the safety of CV301 as a 2 due to the absence of clinical data that supports its efficacy, despite some evidence pointing towards this drug's security."

Answered by AI

What aims are researchers striving to achieve with this clinical experiment?

"This clinical trial, spanning roughly a year's time period, is primarily measuring overall response rate (ORR) for the Triple Therapy. Secondary outcomes encompass Hospitalization Due to PD AEs, Overall Survival and Safety of Quadruple Therapy respectively defined as ratio of participants that are hospitalized due to adverse events attributed to disease progression; assessment of survival per treatment assignment; evaluation of safety combination involving CV301, N-803, M7824 and NHS-IL12 in subjects with advanced small bowel and colorectal cancers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers

Jason Redman 2020. "Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04491955.

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