A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements
Launched by TURNING POINT THERAPEUTICS, INC. · Mar 21, 2017
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called repotrectinib for patients with certain advanced solid tumors that have specific genetic changes known as ALK, ROS1, or NTRK rearrangements. The trial is divided into two phases. In Phase 1, researchers aim to find the safest dose of repotrectinib and assess any side effects. In Phase 2, they will look at how well the treatment works by measuring how many patients have a significant response to the medication and how long those responses last.
To participate in the trial, patients must be at least 18 years old and have a confirmed diagnosis of locally advanced or metastatic solid tumors with the specified genetic changes. They should have at least one measurable tumor and be able to take medication in capsule form. Participants can expect regular check-ups and monitoring for side effects, along with tests to evaluate how well the treatment is working. It's important to note that individuals with certain serious health issues or recent cancer treatments may not be eligible for this study.
Gender
ALL
Eligibility criteria
- • PHASE 1
- Key Inclusion Criteria:
- • 1. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary CNS tumors) (Stage IV, American Joint Committee on Cancer v.7) that harbors an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement by protocol specified tests.
- • 2. ECOG PS 0-1.
- • 3. Age ≥18 (or age ≥ 20 of age as required by local regulation).
- • 4. Capability to swallow capsules intact (without chewing, crushing, or opening).
- • 5. At least 1 measurable target lesion according to RECIST version 1.1. CNS-only measurable disease as defined by RECIST version 1.1 is allowed.
- • 6. Prior cytotoxic chemotherapy is allowed.
- • 7. Prior immunotherapy is allowed.
- • 8. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.
- • 9. Patients with asymptomatic CNS metastases (treated or untreated) and/or asymptomatic leptomeningeal carcinomatosis are eligible to enroll if they satisfy the protocol specified criteria.
- • 10. Baseline laboratory values fulfilling the following requirements:Absolute neutrophils count (ANC) ≥1500/mm3 (1.5 × 109/L); Platelets (PLTs) ≥100,000/mm3 (100 × 109/L); Hemoglobin ≥ 9.0 g/dL transfusions are allowed; Serum creatinine or creatinine clearance Within normal limits or \> 40 mL/min; Total serum bilirubin \< 1.5 × ULN; Liver transaminases (ASTs/ALTs) \< 2.5 × ULN; \< 5 × ULN if liver metastases are present Alkaline phosphatase (ALP); \< 2.5 × ULN; \< 5 × ULN if liver and/or bone metastasis are present; Serum calcium, magnesium, and potassium Normal or CTCAE grade ≤ 1 with or without supplementation
- • 11. Life expectancy ≥ 3 months.
- • PHASE 2 Key Inclusion Criteria
- • 1. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary CNS tumors) that harbors a ROS1, or NTRK1-3 gene fusion.
- 2. Subject must have a documented ROS1 or NTRK1-3 gene fusion determined by tissue-based local testing using either:
- • 1. a next-generation sequencing (NGS) or quantitative polymerase chain reaction (qPCR) test will be accepted to determine molecular eligibility.
- • • Adequate tumor tissue needs to be sent to the Sponsor designated central diagnostic laboratory for retrospective confirmation by a central diagnostic laboratory test selected by the Sponsor.
- • OR
- • 2. a fluorescence in situ hybridization (FISH) test AND prospective confirmation of fusion status by a central diagnostic laboratory test selected by the Sponsor PRIOR to enrollment will be accepted to determine molecular eligibility.
- • Adequate tumor tissue must be sent to the Sponsor designated central diagnostic laboratory for prospective confirmation by a central diagnostic laboratory test selected by the Sponsor PRIOR to enrollment.
- • 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- • 4. Age ≥12 (or age ≥ 20 as required by local regulation).
- • 5. Willing and able to provide written institutional review board (IRB)/institutional ethics committee-approved Informed Consent or an Assent signed by a parent or legal guardian for subjects age 12 to 17.
- • 6. At least 1 measurable target lesion according to RECIST (v1.1) prospectively confirmed by Blinded Independent Central Radiology Review (BICR), selected by Sponsor, PRIOR to enrollment. Subjects with CNS-only measurable disease ≥10 mm as defined by RECIST (v1.1) are eligible.
- • 7. Subjects with advanced solid tumors harboring ROS1, NTRK1, NTRK2, or NTRK3 rearrangement will be assigned into 6 distinct expansion (EXP) cohorts provided all inclusion and exclusion criteria are met.
- • i. EXP-1: ROS1 TKI-naïve ROS1+ NSCLC ii. EXP-2: 1 Prior ROS1 TKI and 1 Platinum based chemo ROS1+ NSCLC iii. EXP-3: 2 Prior ROS1 TKIs ROS1+ NSCLC (No Chemo or IO) iv. EXP-4: 1 Prior ROS1 TKI ROS1+ NSCLC (No Chemo or IO) v. EXP-5: TRK TKI-naïve NTRK+ solid tumors vi. EXP-6: TRK TKI-pretreated NTRK+ solid tumors
- • 8. Subjects with asymptomatic CNS metastases (treated or untreated) and/or asymptomatic leptomeningeal carcinomatosis are eligible to enroll if they satisfy the protocol specified criteria.
- • 9. Baseline laboratory values fulfilling the following requirements:Absolute neutrophils count (ANC) ≥1500/mm3 (1.5 × 109/L); Platelets (PLTs) ≥100,000/mm3 (100 × 109/L); Hemoglobin ≥ 9.0 g/dL transfusions are allowed; Serum creatinine or creatinine clearance \> 40 mL/min; Total serum bilirubin \< 1.5 × ULN; Liver transaminases (ASTs/ALTs) \< 2.5 × ULN; \< 5 × ULN if liver metastases are present Alkaline phosphatase (ALP); \< 2.5 × ULN; \< 5 × ULN if liver and/or bone metastasis are present; Serum calcium, magnesium, and potassium Normal or CTCAE grade ≤ 1 with or without supplementation
- • 10. Life expectancy ≥ 3 months.
- • Key Exclusion Criteria PHASE 1 and PHASE 2
- • 1. Concurrent participation in another therapeutic clinical trial.
- • 2. Symptomatic brain metastases or leptomeningeal involvement.
- • 3. History of previous cancer, except for squamous cell or basal-cell carcinoma of the skin, or any in situ carcinoma that has been completely resected, requiring therapy within the previous 2 years.
- • 4. Major surgery within 4 weeks of start of repotrectinib treatment. Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry. Palliative radiation (≤10 fractions) must have been completed at least 48 hours prior to study entry
- • 5. Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment): myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Classification Class ≥ II), cerebrovascular accident or transient ischemic attack, symptomatic bradycardia, requirement for anti-arrhythmic medication. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2
- 6. Any of the following cardiac criteria:
- • Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTcF) \> 470 msec obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \> 250 msec) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval.
- • 7. Known active infections (bacterial, fungal, viral including HIV positivity).
- • 8. Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption.
- • 9. Peripheral neuropathy of CTCAE ≥grade 2.
- • 10. History of extensive, disseminated, bilateral, or presence of CTCAE grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis. Subjects with history of prior radiation pneumonitis are not excluded.
About Turning Point Therapeutics, Inc.
Turning Point Therapeutics, Inc. is a biopharmaceutical company dedicated to advancing precision medicine in oncology through the development of innovative therapies for patients with cancer. Focused on targeted treatments, the company utilizes cutting-edge science and technology to identify and develop small molecules that address specific genetic mutations and alterations driving tumor growth. With a commitment to improving patient outcomes, Turning Point Therapeutics strives to deliver transformative medicines that enhance the quality of life for individuals facing complex cancer diagnoses. The organization emphasizes collaboration and rigor in its clinical trials, aiming to bring novel therapies from the laboratory to the clinic effectively and efficiently.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ann Arbor, Michigan, United States
Orange, California, United States
Chicago, Illinois, United States
Philadelphia, Pennsylvania, United States
New York, New York, United States
Madrid, , Spain
London, , United Kingdom
Long Beach, California, United States
Goldsboro, North Carolina, United States
Duarte, California, United States
Tampa, Florida, United States
New Brunswick, New Jersey, United States
Baltimore, Maryland, United States
Houston, Texas, United States
Singapore, , Singapore
Dallas, Texas, United States
Canton, Ohio, United States
Peoria, Illinois, United States
Detroit, Michigan, United States
Hollywood, Florida, United States
Aurora, Colorado, United States
Orange, California, United States
Groningen, , Netherlands
Adelaide, South Australia, Australia
Amsterdam, , Netherlands
Fairfax, Virginia, United States
Heidelberg, , Germany
Toon, Ehime, Japan
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Sutton, , United Kingdom
Budapest, , Hungary
Melbourne, Victoria, Australia
Marseille, , France
Manchester, , United Kingdom
Milano, , Italy
New Brunswick, New Jersey, United States
Singapore, , Singapore
Camperdown, New South Wales, Australia
Budapest, , Hungary
Boston, Massachusetts, United States
Nanjing, Jiangsu, China
Toronto, Ontario, Canada
Shanghai, , China
Columbus, Ohio, United States
Kashiwa, , Japan
Pamplona, , Spain
Cleveland, Ohio, United States
Bolivar, Missouri, United States
Xi'an, , China
Beijing, Beijing, China
Hangzhou, Zhejiang, China
Saint Louis, Missouri, United States
Hong Kong, , Hong Kong
Seattle, Washington, United States
Yokohama, Kanagawa, Japan
Santa Rosa, California, United States
Cheongju Si, , Korea, Republic Of
Milano, Mi, Italy
Houston, Texas, United States
Osaka, , Japan
Boston, Massachusetts, United States
Yonago, Tottori, Japan
Athens, Georgia, United States
Madrid, , Spain
Nice, , France
Warszawa, , Poland
New York, New York, United States
Seoul, , Korea, Republic Of
Cincinnati, Ohio, United States
East Melbourne, , Australia
Terni, , Italy
Sapporo Shi, Hokkaido, Japan
Edmonton, Alberta, Canada
Saint Paul, Minnesota, United States
Seoul, Gangnam Gu, Korea, Republic Of
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Camperdown, New South Wales, Australia
Bedford Park, South Australia, Australia
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Edegem, , Belgium
Leuven, , Belgium
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Brampton, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Hefei, Anhui, China
Chaoyang, Beijing, China
Haidian, Beijing, China
Wenjiang, Chengdu, China
Daping, Chongqing, China
Shapingba, Chongqing, China
Fujian, Fujian, China
Fuzhou, Fujian, China
Guangzhou, Guangdong, China
Heilongjiang, Heilongjiang, China
Zhengzhou, Henan, China
Wuhan, Hubei, China
Changsha, Hunan, China
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Nanjing, Jiangsu, China
Xuzhou, Jiangsu, China
Jilin, Jilin, China
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Shanghai, Shanghai, China
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Shanxi, Shanxi, China
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Yuelu, Yuelu, China
Zhanggong, Zhanggong, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
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Copenhagen, , Denmark
Brest, , France
Dijon, , France
Grenoble, , France
Marseille, , France
Nice, , France
Poitiers, , France
Saint Mandé, , France
Villejuif, , France
Berlin, , Germany
Cologne, , Germany
Dresden, , Germany
Heidelberg, , Germany
Hong Kong, , Hong Kong
Kowloon, , Hong Kong
Sha Tin, , Hong Kong
Budapest, , Hungary
Budapest, , Hungary
Aviano, , Italy
Milan, , Italy
Milan, , Italy
Palermo, , Italy
Reggio Emilia, , Italy
Roma, , Italy
Terni, , Italy
Nagoya Shi, Aichi, Japan
Kashiwa, Chiba, Japan
Toon Shi, Ehime, Japan
Sapporo Shi, Hokkaido, Japan
Yokohama Shi, Kanagawa, Japan
Osaka Shi, Osaka, Japan
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Cheongju Si, Chungcheongbuk Do, Korea, Republic Of
Hwasun, Jeollanam Do, Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Amsterdam, , Netherlands
Groningen, , Netherlands
Gdańsk, , Poland
Lublin, , Poland
Poznan, , Poland
Szczecin, , Poland
Warszawa, , Poland
Singapore, Central Singapore, Singapore
Singapore, Central Singapore, Singapore
Pamplona, Navarra, Spain
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Valencia, , Spain
Tainan, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
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Hefei, , China
La Jolla, California, United States
New York, New York, United States
Reggio Emilia, , Italy
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Nagoya Shi, , Japan
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Dijon Cedex, , France
Appleton, Wisconsin, United States
Ottawa, , Canada
Shenyang, Liaoning, China
Harbin, Heilongjiang, China
Taiyuan, Shanxi, China
Guangzhou, Guangdong, China
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Kingwood, Texas, United States
Memphis, Tennessee, United States
Madrid, , Spain
Copenhagen, , Denmark
Washington, District Of Columbia, United States
Columbus, Georgia, United States
Detroit, Michigan, United States
Memphis, Tennessee, United States
Camperdown, New South Wales, Australia
Adelaide, South Australia, Australia
Melbourne, Victoria, Australia
Antwerp, , Belgium
Leuven, , Belgium
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Ontario, , Canada
Ottawa, , Canada
Beijing, Beijing, China
Beijing, Beijing, China
Daping, Chongqing, China
Fuzhou, Fujian, China
Xiamen, Fujian, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Shenzhen, Guangdong, China
Harbin, Heilongjiang, China
Shatin, Hong Kong, China
Changsha, Hunan, China
Changsha, Hunan, China
Nanjing, Jiangsu, China
Xuzhou City, Jiangsu, China
Changchun, Jilin, China
Shenyang, Liaoning, China
Xi'an, Shan3xi, China
Taiyuan, Shanxi, China
Chengdu City, Sichuan, China
Chongqing, Sichuan, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Changchun City, , China
Changchun City, , China
Changsha, , China
Chengdu, , China
Hangzhou, , China
Hefei, , China
Shanghai, , China
Shanghai, , China
Weifang City, , China
Wuhan, , China
Zhengzhou, , China
Marseille, Bouches Du Rhône, France
Brest, , France
Dijon Cedex, , France
Grenoble Cedex 9, , France
Nice, , France
Poitiers, , France
St Mande, , France
Villejuif, , France
Berlin, , Germany
Dresden, , Germany
Heidelberg, , Germany
Koln, , Germany
Hong Kong, , Hong Kong
Hong Kong, , Hong Kong
Budapest, , Hungary
Budapest, , Hungary
Milano, Mi, Italy
Milano, , Italy
Palermo, , Italy
Pordenone, , Italy
Reggio Emilia, , Italy
Roma, , Italy
Terni, , Italy
Toon, Ehime, Japan
Sapporo Shi, Hokkaido, Japan
Yokohama, Kanagawa, Japan
Osaka Shi, Osaka, Japan
Chuo Ku, Tokyo, Japan
Yonago, Tottori, Japan
Kashiwa, , Japan
Nagoya Shi, , Japan
Osaka, , Japan
Seoul, , Korea, Democratic People's Republic Of
Hwasun Eup, Hwasun Gun, Jeonnam, Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Cheongju Si, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Amsterdam, , Netherlands
Groningen, , Netherlands
Gdańsk, , Poland
Lublin, , Poland
Poznań, , Poland
Szczecin, , Poland
Warszawa, , Poland
Singapore, , Singapore
Singapore, , Singapore
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Pamplona, , Spain
Valencia, , Spain
Taiepi, , Taiwan
Tainan, , Taiwan
Taipei, , Taiwan
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Sutton, , United Kingdom
Seoul, Seodaemun Gu, Korea, Republic Of
Daping, Chongqing, China
Xiamen, Fujian, China
Guangzhou, Guangdong, China
Changsha, Hunan, China
Xuzhou City, Jiangsu, China
Xi'an, Shan3xi, China
Chengdu City, Sichuan, China
Hangzhou, Zhejiang, China
Changchun City, , China
Changsha, , China
Chengdu, , China
Hangzhou, , China
Weifang City, , China
Wuhan, , China
Zhengzhou, , China
Pordenone, , Italy
Seoul, , Korea, Republic Of
New York, New York, United States
Orange, California, United States
Aurora, Colorado, United States
Boston, Massachusetts, United States
New York, New York, United States
Leuven, , Belgium
Grenoble Cedex 9, , France
Seoul, Gangnam Gu, Korea, Republic Of
Seoul, , Korea, Republic Of
Poznań, , Poland
Barcelona, , Spain
Seoul, Seodaemun Gu, Korea, Republic Of
La Jolla, California, United States
Columbus, Georgia, United States
Peoria, Illinois, United States
New Orleans, Louisiana, United States
Toledo, Ohio, United States
Tacoma, Washington, United States
Antwerp, , Belgium
Ontario, , Canada
Shatin, Hong Kong, China
Wuhan, Hubei, China
Changchun, Jilin, China
Marseille, Bouches Du Rhône, France
Villejuif, , France
Dresden, , Germany
Koln, , Germany
Ravenna, , Italy
Roma, , Italy
Hwasun Eup, Hwasun Gun, Jeonnam, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Gdańsk, , Poland
Barcelona, , Spain
Madrid, , Spain
Valencia, , Spain
Taiepi, , Taiwan
London, , United Kingdom
Glendale, California, United States
Washington, District Of Columbia, United States
Tampa, Florida, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Saint Paul, Minnesota, United States
Bolivar, Missouri, United States
New Brunswick, New Jersey, United States
Goldsboro, North Carolina, United States
Canton, Ohio, United States
Cleveland, Ohio, United States
Houston, Texas, United States
Kingwood, Texas, United States
Changchun, Jilin, China
Chongqing, Sichuan, China
Osaka Shi, Osaka, Japan
Chuo Ku, Tokyo, Japan
Duarte, California, United States
La Jolla, California, United States
Long Beach, California, United States
Orange, California, United States
Santa Rosa, California, United States
Aurora, Colorado, United States
Washington, District Of Columbia, United States
Hollywood, Florida, United States
Athens, Georgia, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Saint Louis, Missouri, United States
New York, New York, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Fairfax, Virginia, United States
Seattle, Washington, United States
Appleton, Wisconsin, United States
East Melbourne, , Australia
Marseille, , France
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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