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Cancer Vaccine

Immunotherapy + Chemotherapy for Metastatic Colorectal Cancer

Phase 2

Waitlist Available

Led By Kristen N Spencer, M.D.

Research Sponsored by Kristen Spencer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed hepatic-limited metastatic colorectal cancer.

Renal: Creatinine < 1.5 x ULN OR Calculated Creatinine Clearance ≥ 60 mL/min

Must not have

Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.

History of allogenic stem cell or solid organ transplant.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is a multi-center Phase II randomized study of a new cancer treatment. 78 patients with liver metastases from colorectal cancer will be enrolled and randomly assigned to either the control arm or the experimental arm. The control arm will receive the standard of care, while the experimental arm will receive a new immunotherapy treatment in addition to the standard of care. The primary endpoint of the study is to assess the safety and efficacy of the new treatment.

Who is the study for?

This trial is for adults with colorectal cancer that has spread to the liver but can be surgically removed. They must not have had previous treatment for stage IV cancer, though past oxaliplatin therapy is okay if over a year ago. Participants need proper kidney and liver function, no serious allergies or autoimmune diseases, and women of childbearing age must test negative for pregnancy.

What is being tested?

The study compares two groups: one receiving standard chemotherapy (mFOLFOX6) plus Nivolumab; the other getting additional CV301 vaccinations before and after surgery. The goal is to see if adding the vaccine improves outcomes by inducing a stronger immune response against the tumor.

What are the potential side effects?

Possible side effects include reactions related to chemotherapy like nausea, fatigue, blood cell count changes; Nivolumab may cause immune-related issues such as inflammation in organs or skin problems; CV301 could trigger allergic responses due to its egg-based components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My colorectal cancer has spread to the liver only.

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My kidney function is normal or only slightly below normal.

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My liver function tests are within the required ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks.

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I have had a stem cell or organ transplant from another person.

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My cancer has specific genetic mutations related to DNA repair.

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My cancer has spread beyond the liver.

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My disease cannot be fully removed with one surgery without harming my liver.

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I had surgery or chemotherapy for colorectal cancer within the last 6-12 months.

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I have a condition that weakens my immune system, such as HIV/AIDS or chronic Hepatitis B or C.

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I have not had serious heart issues or a stroke in the past year.

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I haven't had any cancer except for certain skin, bladder, prostate, cervix, or breast cancers in the last 3 years.

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I am currently on medication for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Evaluate Best Overall Response Rate (ORR)

Evaluate the perioperative surgical outcomes

Evaluate the proportion of patients amenable to complete resection/ablation

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B - ExperimentalExperimental Treatment4 Interventions

Two doses of Nivolumab and MVA-BN-CV301 each given 2 weeks apart (Days -28, -14), followed by four doses of Nivolumab plus FPV-CV301 given 2 weeks apart concurrently with mFOLFOX6, which will again be administered every 2 weeks for 4 cycles (Nivolumab, FPV-CV301 and mFOLFOX6). After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Patients still considered resectable will undergo surgical resection with the goal of completely treating all of their disease by either resection and/or ablation. Patients with bilobar disease must have all of their disease treated in a single operation. Patients in the experimental arm will receive 8 cycles of mFOLFOX6 in addition to Nivolumab and FVP-CV301 boosters with the first two given on Day 0 and 14 and then every 4 weeks. FVP-CV301 will then be administered every twelve weeks completing therapy at week 110.

Group II: Arm A - ControlActive Control2 Interventions

mFOLFOX6 and Nivolumab every 2 weeks for 4 cycles. After neoadjuvant therapy, patients will be re-evaluated for surgical resection. Patients still considered resectable will undergo surgical resection with the goal of completely treating all of their disease by either resection and/or ablation. Patients with bilobar disease must have all of their disease treated in a single operation. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6 in addition to Nivolumab. After this, Nivolumab will be given every 4 weeks completing therapy at week 110.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MVA-BN-CV301

2020

Completed Phase 2

~20

Nivolumab

2015

Completed Phase 3

~4010