Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer
- Trial number:
- NCT04082364
- Trial phase:
- 2, 3
- Study type:
- Immunotherapy, Chemotherapy
- Overall status:
- Active, not recruiting
Study start date
September, 2019
Scientific title
A Phase 2/3 Trial to Evaluate Margetuximab in Combination With INCMGA00012 and Chemotherapy or MGD013 and Chemotherapy in Patients With Metastatic or Locally Advanced, Treatment-naïve, HER2-Positive Gastric or Gastroesophageal Junction Cancer
Summary
This is a Phase 2/3, randomized, open-label study for the treatment of patients with HER2-positive Gastric cancer (GC) or Gastroesophageal Junction (GEJ) cancer conducted in two parts.
Part A is a single-arm cohort (Cohort A, 40 to 110 patients) will evaluate safety and efficacy of margetuximab plus retifanlimab.
Part B has 2 subparts. Cohort B1 has 4 arms (50 patients/arm). Patients will be randomized to margetuximab plus retifanlimab plus chemotherapy, margetuximab plus tebotelimab, plus chemotherapy, margetuximab plus chemotherapy, or trastuzumab plus chemotherapy. The most effective combination with margetuximab from Cohort B1 will be used in Cohort B2.
Cohort B2 has 2 arms (250 patients/arm). Patients will be randomized to margetuximab plus retifanlimab or tebotelimab plus chemotherapy, or to trastuzumab plus chemotherapy.
Key
Histologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic HER2+ GC or GEJ adenocarcinoma
Prior systemic perioperative treatment is allowed; however the patient must have had a disease-free interval of at least 6 months from end of chemo/surgeryPatients receiving perioperative anti-HER2 therapy require testing of HER2 status for eligibility Cohort A: HER2-positive (by IHC 3+) and PD-L1-positive (by IHC with 22C3 CPS ≥ 1%) per central review Cohort B: HER2-positive (by IHC 3+ or IHC 2+ in combination with FISH+) by local review. PD -L1 status is not required for enrollment. Availability of formalin-fixed, paraffin-embedded tumor specimen, unstained slides or contemporaneous biopsy for tumor target testing Eastern Cooperative Oncology Group performance status of 0 or 1, verified within 3 days of Day 1 Life expectancy ≥ 6 months At least one radiographically measurable target lesion Acceptable laboratory parameters and adequate organ function
Key
Study design
Primary purpose:
Treatment, Allocation:
Randomized, Intervention model:
Parallel Assignment, Intervention model description:
Cohort A is a single-arm cohort to evaluate safety and efficacy of margetuximab plus retifanlimab. Cohort B Part 1 is a randomized, 4-arm segment to evaluate margetuximab plus retifanlimab plus chemotherapy, margetuximab plus tebotelimab plus chemotherapy, margetuximab plus chemotherapy, vs trastuzumab plus chemotherapy. Cohort B Part 2 is a randomized, 2-arm segment to evaluate margetuximab plus the selected checkpoint inhibitor from Part 1, plus chemotherapy vs. trastuzumab plus chemotherapy., Masking:
None (Open Label),
Conditions
Gastric Cancer, Gastroesophageal Junction Cancer, HER2-positive Gastric Cancer
Other study ID numbers
CP-MGAH22-06
Choose trial site (74)
Mayo Clinic - Scottsdale
13400 E Shea Blvd, Scottsdale, AZ 85259, USA
City of Hope Comprehensive Cancer Center - Duarte
1500 E Duarte Rd, Duarte, CA 91010, USA
Norris Comprehensive Cancer Center (USC)
1441 Eastlake Ave, Los Angeles, CA 90033, USA
UCLA School of Medicine
10833 Le Conte Ave, Los Angeles, CA 90095, USA
Yale University
New Haven, CT 06520, USA
Florida Cancer Specialists South
3840 Broadway, Fort Myers, FL 33916, USA
Mayo Clinic - Jacksonville
4500 San Pablo Rd S, Jacksonville, FL 32224, USA
Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala
3130 SW 32nd Ave, Ocala, FL 34474, USA
Florida Cancer Specialists North
1201 5th Ave N Suite 505, St. Petersburg, FL 33705, USA
University of Chicago
5801 S Ellis Ave, Chicago, IL 60637, USA
Edward H. Kaplan MD & Associates
9631 Gross Point Rd #10, Skokie, IL 60076, USA
Massachusetts General Hospital Cancer Center
55 Fruit St, Boston, MA 02114, USA
Henry Ford Health System
1 Ford Pl, Detroit, MI 48202, USA
Cancer & Hematology Centers of Western Michigan - Lemmen-Holton Cancer Pavilion
145 Michigan St NE Ste 3100, Grand Rapids, MI 49503, USA
Mayo Clinic - Rochester
200 1st St SW, Rochester, MN 55905, USA
Washington University School of Medicine
660 S Euclid Ave, St. Louis, MO 63110, USA
Nebraska Heme Onc
4004 Pioneer Woods Dr, Lincoln, NE 68506, USA
Rutgers Cancer Institute of New Jersey
195 Little Albany St, New Brunswick, NJ 08901, USA
The University of New Mexico Comprehensive Cancer Center
1201 Camino de Salud, Albuquerque, NM 87102, USA
Stephenson Cancer Center at OUHSC
800 NE 10th St, Oklahoma City, OK 73104, USA
Oregon Health & Science University
3181 SW Sam Jackson Park Rd, Portland, OR 97239, USA
Sarah Cannon Research Institute
250 25th Ave N, Nashville, TN 37203, USA
Oncology Consultants
2130 W Holcombe Blvd 10th floor, Houston, TX 77030, USA
Utah Cancer Specialists
3838 S 700 E #100, Salt Lake City, UT 84106, USA
Virginia Cancer Specialists
8503 Arlington Blvd Suite 400, Fairfax, VA 22031, USA
Swedish Cancer Institute
1221 Madison St, Seattle, WA 98104, USA
Beijing Cancer Hospital
52 Fucheng Rd, Hai Dian Qu, Bei Jing Shi, China
Jilin Cancer Hospital (Second People's Hospital Of Jilin Province)
China, Ji Lin Sheng, Chang Chun Shi, Chao Yang Qu, 工农大路工农大街1183号
Fujian Medical University - Fujian Provincial Cancer Hospital (Fujian Provincial Tumor Hospital)
Fuzhou, Fujian, China
SIR RUN RUN SHAW Hospital, Zhejiang University school of medicine
China, Zhe Jiang Sheng, Hang Zhou Shi, Jiang Gan Qu, 新城商圈采东路
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Affiliated Tumor Hospital of Harbin Medical University- the 3rd Affiliated Hospital of Harbin
China, Hei Long Jiang Sheng, Ha Er Bin Shi, Nan Gang Qu, 保健路157号
The First Affiliated Hospital of Anhui Medical University
218 Jixi Rd, Shu Shan Qu, He Fei Shi, An Hui Sheng, China
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Jinan Center Hospital
105 Jiefang Rd, Li Xia Qu, Ji Nan Shi, Shan Dong Sheng, China
Nanjing University Medical School; Nanjing Drug Tower
140 Hanzhong Rd, Gu Lou Qu, Nan Jing Shi, Jiang Su Sheng, China, 210029
Zhongshan Hospital Fudan University
China, Shang Hai Shi, Xu Hui Qu, 医学院路111号
Liaoning cancer hospital
44 Xiaoheyan Rd, Da Dong Qu, Shen Yang Shi, Liao Ning Sheng, China, 110042
Hebei cancer hospital (The Fourth Affiliate)
Shijiazhuang, Hebei, China
Wuhan Union Hospital
China, Hu Bei Sheng, Wu Han Shi, Xin Zhou Qu, 齐安大道328号
Henan Cancer Hospital
China, He Nan Sheng, Zheng Zhou Shi, Jin Shui Qu, 东明路127号
The First Affiliated Hospital of Zhengzhou University
China, He Nan Sheng, Zheng Zhou Shi, Er Qi Qu, 建设东路1号
Institute of Clinical Cancer Research Krankenhaus Nordwest (IKF)
Institut für Klinische Krebsforschung IKF GmbH, Steinbacher Hohl 2-26, 60488 Frankfurt am Main, Germany
Haematologisch-Onkologische Praxis Eppendorf
Eppendorfer Landstraße 42, 20249 Hamburg, Germany
Universitätsmedizin Mainz
Langenbeckstraße 1/Gebäude 109, 55131 Mainz, Germany
Kliniken Maria Hilf GmbH
Viersener Str. 450, 41063 Mönchengladbach, Germany
Ospedale San Raffaele
Via Olgettina, 60, 20132 Milano MI, Italy
Azienda Ospedaliero-Universitaria Pisana
Via Roma, 67, 56126 Pisa PI, Italy
Hallym University Sacred Heart Hospital
South Korea, Gyeonggi-do, Anyang, Dongan-gu, Gwanpyeong-ro 170beon-gil, 22 KR
CHA bundang
Bundang Cha Medical Center, Bundang Public Health Center, Seongnam-si, South Korea
Inje University Haeundae Paik Hospital
875 Haeun-daero, Haeundae, Busan, South Korea
Seoul National University Bundang Hospital
South Korea, Gyeonggi-do, Seongnam-si, Bundang-gu, Gumi-ro 173(baekchilsipsam)beo, 82 KR
Asan Medical Center
88 Olympic-ro 43-gil, Songpa-gu, Seoul, South Korea
Korea University Guro
148 Gurodong-ro, Guro-dong, Guro-gu, Seoul, South Korea
Korea University, Anam Hospital
South Korea, Seoul, Seongbuk-gu, 고려대로 73
Samsung Medical Center
81 Irwon-ro, Gangnam-gu, Seoul, South Korea
Seoul National University Hospital
South Korea, Seoul, Jongno-gu, Daehak-ro, 101 서울대학교암병원
Yonsei University College of Medicine (Severance Hospital)
50-1 Yonsei-ro, Sinchon-dong, Seodaemun-gu, Seoul, South Korea
Catholic University of Korea St. Vincent Hospital
93 Jungbu-daero, Paldal-gu, Suwon, Gyeonggi-do, South Korea
SPSK nr 1 in Lublin
Stanisława Staszica 16, 20-400 Lublin, Poland
Centrum Medyczne MrukMed
Partyzantów 28/30a, 35-234 Rzeszów, Poland
National University Hospital 119074
Singapore 119074
National Cancer Centre Singapore
11 Hospital Cres, Singapore 169610
Taipei Medical University Hospital
No. 252號, Wuxing Street, Xinyi District, Taipei City, Taiwan 110
Kaohsiung Chang Gung MemorialHospital
No. 123號, Dapi Rd, Niaosong District, Kaohsiung City, Taiwan 833
Chang Gung Memorial Hospital, Keelung
No. 222, Maijin Rd, Anle District, Keelung City, Taiwan 204
Liuying Chi MeiMedical Hospital
Liuying District, Tainan City, Taiwan 736
National Taiwan University
No. 1, Section 4, Roosevelt Rd, Da’an District, Taipei City, Taiwan 10617
Salinas Memorial
450 E Romie Ln, Salinas, CA 93901, USA
Kaiser Permanente
1010 Pensacola St, Honolulu, HI 96814, USA
University of Wisconsin
Madison, WI, USA
Istituto Europeo Di Oncologia
Via Giuseppe Ripamonti, 435, 20141 Milano MI, Italy
Cambridge University Hospitals NHS Foundation Trust Addenbrooke's Hospital
Hills Rd, Cambridge CB2 0QQ, UK
The Christie Hospital NHS Foundation Trust
Wilmslow Rd, Manchester M20 4BX, UK