An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer Patients

NCT04099641 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: ONCG1002019-000949-13KEYNOTE PN978
• Study Type: interventional
• Target: 80
• Locations: 4 countries
• Sites: 21

Brief Summary

This study evaluates the combination of bavituximab and pembrolizumab in the treatment of gastric and gastroesphogeal cancer. All patients will receive both bavituximab, a drug that is not yet approved by the FDA, and pembrolizumab known as Keytruda. There is no expanded access program available for the investigational agents per this protocol.

Conditions

Gastric Cancer; GastroEsophageal Cancer

Outcome Measures

Primary Outcomes (3)

• Number of Patients With Treatment Emergent Adverse Events (TEAE)

  Incidence of TEAEs graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, including changes in clinical laboratory parameters. TEAEs: any AE that emerged on or after first dose, and within 30 days of the last dose.

  From first dose through 30 days after last dose. Maximum exposure: 567 days.

• Severity of Treatment Emergent Adverse Events (TEAE)

  Severity of TEAEs graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0, including changes in clinical laboratory parameters. TEAEs: any AE that emerged on or after first dose, and within 30 days of the last dose.

  From first dose through 30 days after last dose. Maximum exposure: 567 days.

• Objective Response Rate (ORR)

  ORR was based on RECIST version 1.1 criteria for target lesions, where a patient may achieve as best overall response (BOR) either complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline summary of diameters. ORR is calculated as the number of patients achieving a CR or PR (objective response) divided by the number of efficacy patients.

  From date of first dose until the date of CR, PR, first documented progression or date of death from any cause, whichever came first. Maximum exposure: 567 days.

Study Arms (1)

bavituximab and pembrolizumab

EXPERIMENTAL

Bavituximab 3mg/kg IV weekly in combination with pembrolizumab 200mg IV given once every 3 weeks

Drug: Bavituximab; Drug: Pembrolizumab Injection

Interventions

Bavituximab DRUG

Bavituximab IV infusion

bavituximab and pembrolizumab

Pembrolizumab Injection DRUG

Pembrolizumab IV Infusion

Also known as: Keytruda

bavituximab and pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• Men and women ≥ 18 years old; ≥ 20 years old in South Korea and Taiwan
• Unresectable metastatic or locally advanced gastric or GEJ adenocarcinoma
• Progressed on and/or after at least 1 prior regimen for metastatic disease or achieved stable disease or better in two consecutive scans to PD-1/PD-L1 inhibition alone or in combination with chemotherapy and relapsed
• Willing and able to provide fresh formalin-fixed paraffin-embedded tissue tumor sample
• Presence of at least one measurable lesion
• ECOG of 0 or 1
• Has adequate organ functions
• Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of study treatment.
• Women must not be breastfeeding.
• Women of childbearing potential , must agree to follow instructions for highly effective method(s) of contraception
• Males who are sexually active with women of childbearing potential must agree to follow instructions for highly effective method(s) of contraception
• Has adequate treatment washout period before start of study treatment

You may not qualify if:

• Received any form of anti-phosphatidylserine therapies
• Prior treatment with any checkpoint inhibitor or other therapies targeting T-cell control
• Known microsatellite instability-high (MSI-H) gastric or GEJ adenocarcinoma
• Medical history of myocardial infarction within 6 months before registration, symptomatic congestive heart failure (CHF) , troponin levels consistent with myocardial infarction, unstable angina, or serious cardiac arrhythmia
• Weight loss \>10% over 2 months prior to first dose of study treatment
• History of pneumonitis that required steroids or has current pneumonitis
• Has known active CNS metastases/and or carcinomatous meningitis
• Known additional malignancy that is progressing or has required active treatment in within the past 3 years
• An active infection requiring systemic therapy
• Known human immunodeficiency virus (HIV) infection or known acute hepatitis B or C infection
• Unresolved toxicities from previous cancer treatments
• History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
• Active autoimmune disease or history of chronic recurrent autoimmune disease
• Severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.
• History of infusion reactions to any component/excipient of bavituximab

Sponsors & Collaborators

• OncXerna Theraputics, Inc.: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (21)

Smilow Cancer Hospital at Yale-New Haven

New Haven, Connecticut, 06511, United States

Location

Cleveland Clinic Florida - Weston

Weston, Florida, 33331, United States

Location

Columbus Regional Research Institute

Columbus, Georgia, 31904, United States

Location

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Siteman Cancer Center - Washington University Medical Campus

St Louis, Missouri, 63110, United States

Location

White Plains Hospital - Center for Cancer Care

White Plains, New York, 10601, United States

Location

UC Health Office of Clinical Research

Cincinnati, Ohio, 45229, United States

Location

Cancer Treatment Centers of America at Eastern Regional Medical Center

Philadelphia, Pennsylvania, 19124, United States

Location

Sara Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Dong-A University Hospital

Busan, 49201, South Korea

Location

Kyungpook National University Chilgok Hospital

Daegu, 702-210, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Chang Gung Medical Foundation - Linkou Branch

Taoyuan District, 33305, Taiwan

Location

The Royal Marsden

London, SW3 6JJ, United Kingdom

Location

Sarah Cannon Research Institute

London, W1G 6AD, United Kingdom

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

bavituximab; pembrolizumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Results Point of Contact

• Title: CDO, OncXerna Therapeutics, Inc.
• Organization: OncXerna Therapeutics, Inc.

medical@oncxerna.com

(781) 907-7810

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 23, 2019
• Study Start: September 11, 2019
• Primary Completion: December 20, 2021
• Study Completion: October 26, 2022
• Last Updated: February 8, 2023
• Results First Posted: February 8, 2023

Record last verified: 2022-12

Locations

KR (6); US (9); TW (4); GB (2)