Study to Evaluate the Efficacy and Safety of Andecaliximab Combined With Nivolumab Versus Nivolumab Alone in Adults With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT02864381|
Recruitment Status : Completed
First Posted : August 12, 2016
Results First Posted : September 18, 2020
Last Update Posted : September 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma||Drug: Andecaliximab Drug: Nivolumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of GS-5745 Combined With Nivolumab Versus Nivolumab Alone in Subjects With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma|
|Actual Study Start Date :||September 1, 2016|
|Actual Primary Completion Date :||November 8, 2017|
|Actual Study Completion Date :||August 23, 2019|
Experimental: Andecaliximab + Nivolumab
Andecaliximab 800 mg plus nivolumab 3 mg/kg administered every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 34 weeks at the time of the primary efficacy analysis; up to 101 weeks at the time of the safety follow-up analysis).
800 mg administered via IV infusion
Other Name: GS-5745
3 mg/kg administered via IV infusion
Active Comparator: Nivolumab
Nivolumab 3 mg/kg administered every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent (up to 41 weeks at the time of the primary efficacy analysis; up to 97 weeks at the time of the safety follow-up analysis).
3 mg/kg administered via IV infusion
- Objective Response Rate (ORR) [ Time Frame: Up to 41 weeks ]ORR was defined as the percentage of participants with confirmed overall best response of complete response (CR) or partial response (PR) after starting study drug but before starting any new chemotherapy or radiotherapy as assessed by the investigator according to Response Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- Progression Free Survival (PFS) [ Time Frame: Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.1 months ]PFS was defined as the interval in months from the date of randomization to the earlier of the first documentation of definitive disease progression or death from any cause. The first definitive progressive disease (PD) was defined as the first radiation therapy, the first clinical PD, and the first confirmed imaging PD, whichever came first. Participants without PD or death and participants with PD after starting new anti-cancer therapy are censored at the last tumor assessment date.
- Overall Survival (OS) [ Time Frame: Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.0 months ]OS was defined as the interval from the date of randomization to death from any cause. Surviving participants are censored at the last date known alive.
- Duration of Response (DOR) [ Time Frame: Andecaliximab + Nivolumab median follow-up time: 7.0 months; Nivolumab median follow-up time: 7.1 months ]DOR was defined as the interval from the date of the first response (complete or partial response) was achieved to the earlier of the first documentation of definitive disease progression or death from any cause.
- Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months ]An adverse event (AE) is any untoward medical occurrence in a clinical study participants administered a medicinal product, which does not necessarily have a causal relationship with the treatment. TEAEs are events that are defined as AEs with onset dates on or after the first dose of andecaliximab/nivolumab and up to 30 days after permanent discontinuation of andecaliximab or 5 months after permanent discontinuation of nivolumab, or led to premature discontinuation of andecaliximab or nivolumab.
- Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities [ Time Frame: Andecaliximab: First dose date up to last dose (maximum: 101 weeks) + 30 days; Nivolumab: First dose date up to last dose (maximum: 101 weeks) + 5 months ]Treatment-emergent (Chemistry, Hematology, Coagulation, and Urinalysis) laboratory abnormalities were graded per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 where: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening. Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of the last dose of andecaliximab plus 30 days or nivolumab plus 5 months. If the relevant baseline laboratory value is missing, any abnormality of at least Grade 1 observed within the time frame specified above will be considered treatment-emergent. Percentage of participants with any postbaseline Grade 1 or higher laboratory abnormality is reported.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864381
|United States, California|
|Los Angeles, California, United States, 90095|
|San Francisco, California, United States, 94158|
|United States, Illinois|
|Chicago, Illinois, United States, 60637|
|United States, Indiana|
|Fort Wayne, Indiana, United States, 46845|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|New York, New York, United States, 10065|
|Australia, New South Wales|
|Albury, New South Wales, Australia, 2640|
|Wahroonga, New South Wales, Australia, 2076|
|Douglas, Queensland, Australia, 4818|
|Hobart, Tasmania, Australia, 7000|
|La Louvière, Hainaut, Belgium, 7100|
|Gent, Oost-Vlaanderen, Belgium, 9000|
|Leuven, Vlaams Brabant, Belgium, 3000|
|Brest, Finistère, France, 29609|
|Reims, Marne, France, 51092|
|Villejuif, Val-de-Marne, France, 94805|
|Budapest, Hungary, H-1097|
|Debrecen, Hungary, 4032|
|Meldola, Forli-Cesena, Italy, 47014|
|Genova, Ligura, Italy, 16128|
|Milano, Lombardia, Italy, 20132|
|Pisa, Toscana, Italy, 56126|
|Brzozow, Podkarpackie, Poland, 36-200|
|Poznań, Poland, 60-693|
|Warszawa, Poland, 02-781|
|Majadahonda, Madrid, Spain, 28222|
|Barcelona, Spain, 08003|
|Barcelona, Spain, 08035|
|Bristol, United Kingdom, BS2 8ED|
|Edgbaston, United Kingdom, B15 2PR|
|London, United Kingdom, EC1A 7BE|
|London, United Kingdom, WC1E 6BT|
|Manchester, United Kingdom, M20 4BX|
|Sutton, United Kingdom, SM2 5PT|
|Study Director:||Gilead Study Director||Gilead Sciences|