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

• ClinicalTrials.gov Identifier: NCT04099641
• Recruitment Status: Recruiting
• First Posted: September 23, 2019
• Last Update Posted: January 28, 2020
• Sponsor: Oncologie Inc.
• Collaborator: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Oncologie Inc.

Tracking Information

• First Submitted Date: September 18, 2019
• First Posted Date: September 23, 2019
• Last Update Posted Date: January 28, 2020
• Actual Study Start Date: September 11, 2019
• Estimated Primary Completion Date: January 15, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 19, 2019)

• Incidence and severity of Treatment Emergent Adverse Events(TEAE) [ Time Frame: From first dose through 30 days after last dose ]
  Incidence by 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
• Objective Response Rate [ Time Frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months ]
  Objective response rate (ORR) as assessed by the Investigator per RECIST version1.1

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Open Label Study of Bavituximab and Pembrolizumab in Advanced Gastric and GEJ Cancer Patients
• Official Title: A Phase 2, Multicenter Open-label, Non-randomized Study of Bavituximab Plus Pembrolizumab in Patients With Advanced Gastric or Gastroesophageal Cancer Who Have Progressed on or After at Least One Prior Standard Therapy

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Gastric Cancer
• GastroEsophageal Cancer

Intervention

• Drug: Bavituximab
  Bavituximab IV infusion
• Drug: Pembrolizumab Injection
  Pembrolizumab IV Infusion
  Other Name: Keytruda

Study Arms

Experimental: bavituximab and pembrolizumab

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

Interventions:

• Drug: Bavituximab
• Drug: Pembrolizumab Injection

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 19, 2019): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 15, 2021
• Estimated Primary Completion Date: January 15, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• 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
• History of severe hypersensitivity reactions to mAbs.
• Systemic steroid therapy within 7 days prior to the first dose of study treatment
• Has received a live vaccine within 30 days prior to first dose of study drug.
• Prior organ transplantation including allogeneic or autologous stem-cell transplantation
• Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
• Receipt of treatment with immunotherapy, biological therapies, or therapeutic doses of hormonal therapies within 3 weeks of scheduled C1D1 dosing
• Known psychiatric, substance abuse disorder, or geographical travel limitations that would interfere with participant's ability to cooperate with the requirements of the study
• Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Oncologie Inc.; 1-781-907-7810; medical@oncologie.international

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04099641
• Other Study ID Numbers: ONCG100; 2019-000949-13 ( EudraCT Number ); KEYNOTE PN978 ( Other Identifier: Merck )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Oncologie Inc.
• Study Sponsor: Oncologie Inc.
• Collaborators: Merck Sharp & Dohme Corp.
• Investigators: Not Provided
• PRS Account: Oncologie Inc.
• Verification Date: January 2020