Neoadjuvant Botensilimab and Balstilimab for the Treatment of Advanced Resectable Colorectal Cancer NEST3

Part of paid clinical trials in Goodyear, Arizona.

Sponsor
City of Hope Medical Center
Study ID
NCT07595874
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Colon Adenocarcinoma
  • Advanced Colorectal Adenocarcinoma
  • Advanced Rectal Adenocarcinoma
  • Stage IIB Colon Cancer AJCC v8
  • Stage IIB Rectal Cancer AJCC v8
  • Stage IIC Colon Cancer AJCC v8
  • Stage IIC Rectal Cancer AJCC v8
  • Stage IIIA Colon Cancer AJCC v8
  • Stage IIIA Rectal Cancer AJCC v8
  • Stage IIIB Colon Cancer AJCC v8
  • Stage IIIB Rectal Cancer AJCC v8
  • Stage IIIC Colon Cancer AJCC v8
  • Stage IIIC Rectal Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Balstilimab — BIOLOGICAL
    Given IV
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Botensilimab — BIOLOGICAL
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI

Study Details

This phase II trial tests how well giving botensilimab and balstilimab prior or to surgery (neoadjuvent) works for the treatment of colorectal cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and that can be removed by surgery (resectable) colorectal cancer. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving botensilimab and balstilimab before surgery may make the tumor smaller. Giving neoadjuvant botensilimab and balstilimab may be effective for the treatment of advanced resectable colorectal cancer.

Key Dates

Start date
Dec 27, 2026
Status verified
May 2026
Primary completion
May 27, 2027
Completion
May 27, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (botensilimab and balstilimab)
    Patients receive botensilimab IV, over 30 minutes, on day 1 and balstilimab IV, over 30 minutes, on days 1, 15, 29 and 43 in the absence of disease progression or unacceptable toxicity. 5-16 weeks later, patients then undergo standard of care resection surgery. Patients undergo CT scan and/or MRI and blood sample collection throughout the study.

Primary Outcome Measure

Two-year disease-free survival rate [ Time Frame: At 2 years post enrollment ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
CTCA at Western Regional Medical CenterGoodyearArizona85338
Pashtoon M. Kasi
[email protected]
949-671-4673
Pashtoon M. Kasi (PRINCIPAL_INVESTIGATOR)
City of Hope CoronaCoronaCalifornia92882
Pashtoon M. Kasi
[email protected]
949-671-4673
Pashtoon M. Kasi (PRINCIPAL_INVESTIGATOR)
City of Hope Medical CenterDuarteCalifornia91010
Pashtoon M. Kasi
[email protected]
949-671-4673
Pashtoon M. Kasi (PRINCIPAL_INVESTIGATOR)
City of Hope SeacliffHuntington BeachCalifornia92648
Pashtoon M. Kasi
[email protected]
949-671-4673
Pashtoon M. Kasi (PRINCIPAL_INVESTIGATOR)
City of Hope at Irvine LennarIrvineCalifornia92618
Pashtoon M. Kasi
[email protected]
949-671-4673
Pashtoon M. Kasi (PRINCIPAL_INVESTIGATOR)
City of Hope at Long Beach ElmLong BeachCalifornia90813
Pashtoon M. Kasi
[email protected]
949-671-4673
Pashtoon M. Kasi (PRINCIPAL_INVESTIGATOR)
City of Hope South PasadenaSouth PasadenaCalifornia91030
Pashtoon M. Kasi
[email protected]
949-671-4673
Pashtoon M. Kasi (PRINCIPAL_INVESTIGATOR)
City of Hope UplandUplandCalifornia91786
Pashtoon M. Kasi
[email protected]
949-671-4673
Pashtoon M. Kasi (PRINCIPAL_INVESTIGATOR)
City of Hope Atlanta Cancer CenterNewnanGeorgia30265
Pashtoon M. Kasi
[email protected]
949-671-4673
Pashtoon M. Kasi (PRINCIPAL_INVESTIGATOR)
City of Hope at Illinois Chicago DowntownChicagoIllinois60611
Pashtoon M. Kasi
[email protected]
949-671-4673
Pashtoon M. Kasi (PRINCIPAL_INVESTIGATOR)
City of Hope at ChicagoZionIllinois60099
Pashtoon M. Kasi
[email protected]
949-671-4673
Pashtoon M. Kasi (PRINCIPAL_INVESTIGATOR)

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