A Single Arm Phase II Study to Evaluate Treatment With Gevokizumab in Patients With Stage II/III Colon Cancer Who Are ctDNA-positive After Curative Surgery and Adjuvant Chemotherapy

  • STATUS
    Recruiting
  • End date
    Feb 15, 2027
  • participants needed
    31
  • sponsor
    NSABP Foundation Inc
Updated on 15 October 2022

Summary

This study will look at the recurrence-free survival of microsatellite-stable (MSS) colon cancer in patients are ctDNA (circulating tumor DNA) positive and treated with gevokizumab.

Description

NSABP FC-12 is a single-arm, multi-centered phase II study to evaluate recurrence-free survival in patients with stage II/III microsatellite-stable (MSS) colon cancer who have undergone curative surgery, adjuvant chemotherapy, are ctDNA (circulating tumor DNA)-positive and treated with gevokizumab.

Patients with stage III resected MSS colon cancer (CRC) who are less than or equal to (≤) 6 weeks after completion of at least 3 months of a standard adjuvant chemotherapy regimen, who are interested in participating in the FC-12 study are eligible for pre-entry ctDNA testing for ctDNA-positivity using the Signatera™ assay via the FC-12 study. Within 6 weeks after completion of adjuvant therapy, stage III patients who have signed the FC-12 Pre-Screening ctDNA consent will have blood and primary tissue samples collected and submitted to Natera for ctDNA evaluation. Commercial ctDNA assay results will not be accepted for study entry. For 150 patients screened in this CRC population, the ctDNA-positivity rate is expected to be approximately 20%.

Note: Patients with stage II MSS colon cancer who were determined to be ctDNA-positive by Natera's Signatera™ commercial assay (i.e., outside of the study) after curative resection may be considered for ctDNA confirmation of ctDNA-positivity via the FC-12 study provided that all the following are met:

  • The patient has completed of at least 3 months of a standard adjuvant chemotherapy regimen.
  • ctDNA samples will be collected and submitted for ctDNA-positivity confirmation by the Signatera™ assay via the FC-12 study within ≤ 8 weeks after the patient has completed adjuvant chemotherapy.
  • The patient otherwise meets eligibility criteria. And,
  • the patient will be able to start study therapy within 14 weeks after completion of adjuvant chemotherapy.

All eligible consenting patients who have ctDNA-positivity confirmed via the FC-12 study must begin study therapy within 14 weeks from the completion of adjuvant chemotherapy. Patients will receive gevokizumab (120mg IV) on Day 1 of every 28-day cycle for a maximum of 1 year (e.g., 13 cycles: 1 cycle = 28 days). Patients will continue to receive 13 cycles (1 year) of study therapy unless the patient elects to discontinue study medication, does not adhere to the study per the investigator, experiences intolerable drug toxicity, or has disease recurrence confirmed by imaging.

ctDNA will be monitored at Weeks 8, 12, 24, 36, 48, 60, and 72 unless disease recurrence is documented by imaging. Imaging will include CT scan of chest, abdomen and pelvis and will occur every 24 weeks (6 months) for the duration of the patient's participation in the study or until imaging confirms recurrence.

All patients will be followed for approximately 18 months after initiating study therapy or until imaging confirms recurrence whichever comes first.

The sample size and maximum enrollment for this single arm phase II trial is approximately 31 patients with stage II patient accrual capped at no more than 8 patients. Enrolled patients who withdraw consent prior to receiving study therapy or who are unable to begin study therapy will be replaced.

Safety assessments will occur at intervals per protocol (Section 5.0). Drug toxicity will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 (CTCAE 5.0).

Submission of archived tumor tissue and blood for FC-12 correlative science studies will be a requirement for all patients enrolled into the study. Serial blood samples will be collected at specified time points throughout the study for gevokizumab pharmacokinetics (PKs) and anti-drug antibody (ADA) assessment.

Stool samples for FC-12 correlative science microbiome studies are optional.

Details
Condition Colon Cancer
Treatment Gevokizumab, Signatera test
Clinical Study IdentifierNCT05178576
SponsorNSABP Foundation Inc
Last Modified on15 October 2022

Eligibility

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note