RECRUITING

A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gastro-esophageal Junction Cancer

Conditions

Metastatic Esophageal Carcinoma Advanced Unresectable Gastric Adenocarcinoma Metastatic Gastric Cancer Metastatic Gastroesophageal Junction Adenocarcinoma Metastatic Esophageal Cancer Metastatic Esophageal Adenocarcinoma Metastatic Gastric Adenocarcinoma Metastatic Gastric Carcinoma Unresectable Esophageal Cancer Unresectable Esophageal Adenocarcinoma Unresectable Gastric Carcinoma Unresectable Gastric Adenocarcinoma Unresectable Gastroesophageal Junction Adenocarcinoma 23-261 Memorial Sloan Kettering Cancer Center

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Participants will receive study treatment with agenT-797, botensilimab, balstilimab, ramucirumab, and paclitaxel. When participants start each agent will depend on how their disease is affecting them.

Official Title

A Phase II Study of agenT-797 (Invariant Natural Killer T Cells), Botensilimab, a Novel Fc-enhanced CTLA-4 Inhibitor, Plus Balstilimab (Anti-PD-1) With Ramucirumab and Paclitaxel for Patients With Previously Treated, Advanced Esophageal, Gastric, or Gastro-esophageal Junction Adenocarcinoma

Quick Facts

Study Start:2024-02-01

Study Completion:2027-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06251973

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Metastatic or advanced unresectable adenocarcinoma of esophageal, gastric, or gastroesophageal junction * Disease progression on one prior line of therapy for metastatic disease. Patients with previously untreated advanced unresectable or metastatic disease may be included if disease progressed or recurred during neoadjuvant or adjuvant therapy or within 6 months of completion of those treatments. * Patients must have histologically or cytologically confirmed esophageal, gastric, or gastroesophageal junction adenocarcinoma * Patients must have measurable or evaluable disease as defined by RECIST v1.1 criteria. Patients with evaluable disease must be eligible to begin with an induction cycle * Age 18 years or older * ECOG performance status 0 to 1 * Adequate organ function as defined in Table 2	* Received prior therapy with ramucirumab at any time * Received paclitaxel or docetaxel-based therapy within 6 month of study enrollment * Had a prior grade \>3 immune related adverse event due to anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA4 therapy at any time * Diagnosis of immunodeficiency or receipt of systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of trial treatment. Replacement therapy (ie physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic immunosuppressive therapy and is allowed. * History of gastrointestinal perforation or fistulae * A known history of active Bacillus tuberculosis * Known active central nervous system metastases and/or carcinomatous meningitis * History of or any evidence of active, non-infectious, immune-mediated pneumonitis. Patients with radiation-induced pneumonitis who are asymptomatic are permitted on study. * Peripheral neuropathy limiting ADLs * A known history of human immunodeficiency virus (HIV 1/2 antibodies) * Known active hepatitis B (e.g., HBsAg reactive) or hepatitis C (e.g., HCV RNA \[qualitative\] is detected). Patients with HBsAg reactive on entecavir may be eligible after consultation with hepatologist and study team. * Received a live vaccine within 30 days of planned start of study therapy * Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial * Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the prescreening or screening visit through 5 months after the last dose of trial treatment * Unwilling to give written, informed consent, unwilling to participate, or unable to comply with the protocol for the duration of the study

Inclusion Criteria

Exclusion Criteria

* Metastatic or advanced unresectable adenocarcinoma of esophageal, gastric, or gastroesophageal junction
* Disease progression on one prior line of therapy for metastatic disease. Patients with previously untreated advanced unresectable or metastatic disease may be included if disease progressed or recurred during neoadjuvant or adjuvant therapy or within 6 months of completion of those treatments.
* Patients must have histologically or cytologically confirmed esophageal, gastric, or gastroesophageal junction adenocarcinoma
* Patients must have measurable or evaluable disease as defined by RECIST v1.1 criteria. Patients with evaluable disease must be eligible to begin with an induction cycle
* Age 18 years or older
* ECOG performance status 0 to 1
* Adequate organ function as defined in Table 2

* Received prior therapy with ramucirumab at any time
* Received paclitaxel or docetaxel-based therapy within 6 month of study enrollment
* Had a prior grade \>3 immune related adverse event due to anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA4 therapy at any time
* Diagnosis of immunodeficiency or receipt of systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of trial treatment. Replacement therapy (ie physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic immunosuppressive therapy and is allowed.
* History of gastrointestinal perforation or fistulae
* A known history of active Bacillus tuberculosis
* Known active central nervous system metastases and/or carcinomatous meningitis
* History of or any evidence of active, non-infectious, immune-mediated pneumonitis. Patients with radiation-induced pneumonitis who are asymptomatic are permitted on study.
* Peripheral neuropathy limiting ADLs
* A known history of human immunodeficiency virus (HIV 1/2 antibodies)
* Known active hepatitis B (e.g., HBsAg reactive) or hepatitis C (e.g., HCV RNA \[qualitative\] is detected). Patients with HBsAg reactive on entecavir may be eligible after consultation with hepatologist and study team.
* Received a live vaccine within 30 days of planned start of study therapy
* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
* Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the prescreening or screening visit through 5 months after the last dose of trial treatment
* Unwilling to give written, informed consent, unwilling to participate, or unable to comply with the protocol for the duration of the study

Contacts and Locations

Study Contact

Yelena Janjigian, MD

CONTACT

646-888-4186

janjigiy@mskcc.org

Geoffrey Ku, MD

CONTACT

646-888-4588

kug@mskcc.org

Principal Investigator

Yelena Janjigian, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activities)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Yelena Janjigian, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-01

Study Completion Date2027-08-01

Study Record Updates

Study Start Date2024-02-01

Study Completion Date2027-08-01

Terms related to this study

Keywords Provided by Researchers

Metastatic Esophageal Carcinoma
Advanced Unresectable Gastric Adenocarcinoma
Metastatic Gastric Cancer
Metastatic Gastroesophageal Junction Adenocarcinoma
Metastatic Esophageal Cancer
Metastatic Esophageal Adenocarcinoma
Metastatic Gastric Adenocarcinoma
Metastatic Gastric Carcinoma
Unresectable Esophageal Cancer
Unresectable Esophageal Adenocarcinoma
Unresectable Gastric Carcinoma
Unresectable Gastric Adenocarcinoma
Unresectable Gastroesophageal Junction Adenocarcinoma
23-261
Memorial Sloan Kettering Cancer Center

Additional Relevant MeSH Terms

Metastatic Esophageal Carcinoma
Advanced Unresectable Gastric Adenocarcinoma
Metastatic Gastric Cancer
Metastatic Gastroesophageal Junction Adenocarcinoma
Metastatic Esophageal Cancer
Metastatic Esophageal Adenocarcinoma
Metastatic Gastric Adenocarcinoma
Metastatic Gastric Carcinoma
Unresectable Esophageal Cancer
Unresectable Esophageal Adenocarcinoma
Unresectable Gastric Carcinoma
Unresectable Gastric Adenocarcinoma
Unresectable Gastroesophageal Junction Adenocarcinoma