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Pancreatic Cancer MetastaticPhase 1NCT04799431

Neoantigen-Targeted Vaccine Combined With Anti-PD-1 Antibody for Patients With Stage IV MMR-p Colon and Pancreatic Ductal Cancer

A Phase 1 study testing Neoantigen Vaccine with Poly-ICLC adjuvant and Retifanlimab in people with Pancreatic Cancer Metastatic and Colorectal Cancer Metastatic, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Phase 1 study evaluating feasibility, safety, and immune response to a personalized neoantigen vaccine combined with retifanlimab for MMR-p mCRC and mPDAC patients with measurable disease following first-line FOLFIRINOX/FOLFOXIRI (FFX). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Neoantigen Vaccine with Poly-ICLC adjuvant and Retifanlimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
3 May 2023to 3 May 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years.
  • Have histologically or cytologically - proven cancer of the pancreas or colon.
  • Have tumor lesions amenable to repeated biopsy, and patient's acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator).
  • Measurable disease as per RECIST 1.1.
  • Have sufficient and accessible tissue for NGS and immune-phenotyping.
  • Have not received any prior systemic therapy in the metastatic setting for PDA or CRC. Patients who have received adjuvant chemotherapy >12 months prior to the diagnosis of metastatic disease may be eligible.
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  • ECOG performance status 0.
  • Life expectancy of greater than 6 months.
  • Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug.
  • Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol.
  • Men must use acceptable form of birth control while on study.
  • Ability to understand and willingness to sign a written informed consent document.

Who cannot join

  • Is a candidate for definitive surgical resection.
  • Is unwilling or unable to undergo standard of care therapy.
  • Known history or evidence of brain metastases and/or leptomeningeal spread.
  • Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.).
  • Receiving active immunosuppressive agents or chronic use of systemic corticosteroids within 14 days of vaccine treatment.
  • Has active autoimmune disease that has required systemic treatment in the past 5 years, or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
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  • Known history or concurrent interstitial lung disease.
  • Has a pulse oximetry < 95% on room air.
  • Requires the use of home oxygen.
  • Infection with HIV or hepatitis B or C.
  • Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Has been diagnosed with another cancer or myeloproliferative disorder within the past 5 year.
  • Has had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.), celiac plexus block, and biliary stent placement.
  • Has received any non-oncology live vaccine therapy used for prevention of infectious diseases within 28 days of study treatment.
  • If at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or other substance abuse (including alcohol) that could potentially interfere with adherence to study procedures or requirements.
  • Any other sound medical, psychiatric, and/or social reason as determined by the Investigator.
  • Unwilling or unable to follow the study schedule for any reason.
  • Are pregnant or breastfeeding.
  • Any radiological or clinical pleural effusions or ascites.
  • Any peritoneal involvement by the tumor.
  • History of malignant small bowel obstruction.
  • On parenteral nutrition.
  • Any liver metastasis greater than 3 cm or greater than 5 liver metastases.
  • Known or suspected hypersensitivity to Hiltonol.

About this study

Official title: A Pilot Study of a Neoantigen-Targeted Vaccine Combined With Anti-PD-1 Antibody for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Adenocarcinoma

Phase 1 study evaluating feasibility, safety, and immune response to a personalized neoantigen vaccine combined with retifanlimab for MMR-p mCRC and mPDAC patients with measurable disease following first-line FOLFIRINOX/FOLFOXIRI (FFX).

Being tested
Neoantigen Vaccine with Poly-ICLC adjuvant, Retifanlimab
Keywords
Neoantigen Vaccines, Anti-PD-1, Retifanlimab, Cancer Vaccines, Immunotherapy, Colon Cancer, Metastatic colon cancer, Pancreatic Ductal Adenocarcinoma (PDAC), Metastatic pancreatic cancer
Medical subject headings
Colonic Neoplasms, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neoantigen Vaccine with Poly-ICLC adjuvantDrug

    Also called Hiltonol® (Poly-ICLC)

    Neoantigen Vaccine with Poly-ICLC adjuvant will be administered on days 1, 8, 15 and 22. 2 to 5 subcutaneous injections will be administered in the upper thighs, arms and/or back.

    Drug: 0.3 mg per peptide vaccine + 0.5mg Poly-ICLC

  • RetifanlimabDrug

    Also called INCMGA00012; MGA012

    500 mg will be administered as a 30 minute IV. Infusion (-5 min/+15min) on Day 1 of each 28 day cycle every 4 weeks.

Study groups in NCT04799431
Study groupRoleWhat they receive
Neoantigen Vaccine with Poly-ICLC adjuvant and RetifanlimabExperimentalAll participants receive this intervention.
Receives: Drug: Neoantigen Vaccine with Poly-ICLC adjuvant; Drug: Retifanlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients who receive at least one dose of personalized neoantigen vaccine

    Percentage of patients that receive at least one dose of personalized neoantigen vaccine in the maintenance setting among the total number of patients who achieved disease response (eligible for vaccine generation).

    Measured: 9 months

  2. Number of participants experiencing study drug-related toxicities

    Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0.

    Measured: 2 years

Secondary outcomes (8)

  1. Objective Response Rate (ORR) per RECIST 1.1

    ORR is defined as the number of patients who are administered at least 1 dose of personalized neoantigen vaccine achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.

    Measured: 2 years

  2. Objective Response Rate (ORR) per iRECIST

    ORR is defined as the number of patients who are administered at least 1 dose of personalized neoantigen vaccine achieving a complete response (iCR) or partial response (iPR) based on the Response Evaluation Criteria in Solid Tumors (Immune-related RECIST (iRECIST) at any time during the study. iCR = disappearance of all target lesions, iPR is =>30% decrease in sum of diameters of target lesions, progressive disease (iPD) is >20% increase in sum of diameters of target lesions, stable disease (iSD) is <30% decrease or <20% increase in sum of diameters of target lesions.

    Measured: 2 years

  3. Disease Control Rate (DCR)

    DCR is defined as the number of patients achieving a complete response (CR) or partial response (PR) and stable disease (SD) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at 2 months post first vaccination. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.

    Measured: 2 months

  4. Disease Control Rate (DCR)

    DCR is defined as the number of patients achieving a complete response (CR) or partial response (PR) and stable disease (SD) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at 6 months post first vaccination. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.

    Measured: 6 months

  5. Disease Control Rate (DCR)

    DCR is defined as the number of patients achieving a complete response (CR) or partial response (PR) and stable disease (SD) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at 12 months post first vaccination. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.

    Measured: 12 months

  6. Progression-free Survival (PFS) per RECIST 1.1

    PFS is defined as the number of months from the date of first personalized vaccine dose to disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.

    Measured: 4 years

  7. Progression-free Survival (PFS) per iRECIST

    PFS is defined as the number of months from the date of first personalized vaccine dose to disease progression (progressive disease [iPD] or relapse from complete response [iCR] as assessed using RECIST 1.1 criteria) or death due to any cause. Per iRECIST (iPFS) criteria, iCR = disappearance of all target lesions, Partial Response (iPR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (iPD) is >20% increase in sum of diameters of target lesions, Stable Disease (iSD) is <30% decrease or <20% increase in sum of diameters of target lesions.

    Measured: 4 years

  8. Overall Survival (OS)

    OS will be measured as the number of months from date of first personalized vaccine dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2021
  2. Study start3 May 2023
  3. Primary completion3 May 2023
  4. Study completion3 May 2023

Why it stopped: Study never started

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04799431
Sponsor's protocol ID
J2114
Other IDs
IRB00270405, 5P50CA062924
Status last verified
May 2023
First submitted
11 Mar 2021
Last updated
9 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Neoantigen Vaccine with Poly-ICLC adjuvant and Retifanlimab in people with Pancreatic Cancer Metastatic and Colorectal Cancer Metastatic, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients who receive at least one dose of personalized neoantigen vaccine (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04799431.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.

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