A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

NCT ID: NCT03260322

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-08
• Study Completion Date: 2022-05-10

Brief Summary

The primary purpose of this study is to evaluate the tolerability and safety profile of ASP8374 when administered as a single agent and in combination with pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumor malignancies. Also primary purpose is to characterize the pharmacokinetic profile of ASP8374 when administered as a single agent and in combination with pembrolizumab. Last primary purpose of this study is to determine the recommended Phase 2 dose (RP2D) of ASP8374 when administered as a single agent and in combination with pembrolizumab.

The secondary purpose of this study is to evaluate the anti-tumor effect (objective response rate [ORR], duration of response [DOR], persistence of response after discontinuation, and disease control rate [DCR]) of ASP8374 when administered as a single agent and in combination with pembrolizumab.

NTP: Neutropenia

NHAE:Non-haematological AE

GBS: Guillain-Barré syndrome""

IRR: Infusion-related reaction

AST: Aspartate aminotransferase

ALT: Alanine aminotransferase

MS/MG: Myasthenia Syndrome/Myasthenia Gravis

TRT: Treatment-related Toxicity

TCP: Thrombocytopenia

Detailed Description

This is a multi-center, multiple-dose, dose-escalation and expansion study of ASP8374 as a single agent and in combination with pembrolizumab. After discontinuation of study drug treatment (initial treatment and re-treatment), all participants will complete an end of treatment visit along with 30-day and 90-day safety follow-up visits from the last dose of ASP8374. Participants will be enrolled in respectively escalation cohorts or expansion cohorts. The 90-day safety follow-up visit is optional for participants who discontinue due to progressive disease or initiate new anticancer treatment after the last dose of study drug.

Escalation cohorts: Approximately 60 participants may be enrolled in the escalation cohorts (approximately 30 participants for monotherapy and 30 participants for combination therapy).

Expansion cohorts: The total number of subjects in the expansion cohorts will depend on the observed pharmacokinetic and antitumor activity. It is estimated that approximately 240 participants may be enrolled in the monotherapy and combination therapy expansion cohorts.

As the number of participants in the escalation cohorts and the expansion cohorts will depend on the observed Dose Limiting Toxicity (DLT), pharmacokinetics and antitumor activity, approximately 300 participants are expected to be enrolled.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ASP8374 0.5 mg - Monotherapy Dose Escalation

Participants received ASP8374 0.5 mg intravenously, on day 1 of every 3 week cycle for a period of up to 16 cycles or until a discontinuation criterion was met during treatment period. Qualifying participants entered re-treatment period and received treatment for an additional 16 cycles or until a discontinuation criteria was met.

Group Type: EXPERIMENTAL

ASP8374

Intervention Type: DRUG

intravenous

ASP8374 2 mg - Monotherapy Dose Escalation

Participants received ASP8374 2 mg intravenously, on day 1 of every 3 week cycle for a period of up to 16 cycles or until a discontinuation criterion was met during treatment period. Qualifying participants entered re-treatment period and received treatment for an additional 16 cycles or until a discontinuation criteria was met.

Group Type: EXPERIMENTAL

ASP8374

Intervention Type: DRUG

intravenous

ASP8374 7 mg - Monotherapy Dose Escalation

Participants received ASP8374 7 mg intravenously, on day 1 of every 3 week cycle for a period of up to 16 cycles or until a discontinuation criterion was met during treatment period. Qualifying participants entered re-treatment period and received treatment for an additional 16 cycles or until a discontinuation criteria was met.

Group Type: EXPERIMENTAL

ASP8374

Intervention Type: DRUG

intravenous

ASP8374 20 mg - Monotherapy Dose Escalation

Participants received ASP8374 20 mg intravenously, on day 1 of every 3 week cycle for a period of up to 16 cycles or until a discontinuation criterion was met during treatment period. Qualifying participants entered re-treatment period and received treatment for an additional 16 cycles or until a discontinuation criteria was met.

Group Type: EXPERIMENTAL

ASP8374

Intervention Type: DRUG

intravenous

ASP8374 70 mg - Monotherapy Dose Escalation

Participants received ASP8374 70 mg intravenously, on day 1 of every 3 week cycle for a period of up to 16 cycles or until a discontinuation criterion was met during treatment period. Qualifying participants entered re-treatment period and received treatment for an additional 16 cycles or until a discontinuation criteria was met.

Group Type: EXPERIMENTAL

ASP8374

Intervention Type: DRUG

intravenous

ASP8374 200 mg - Monotherapy Dose Escalation

Participants received ASP8374 200 mg intravenously, on day 1 of every 3 week cycle for a period of up to 16 cycles or until a discontinuation criterion was met during treatment period. Qualifying participants entered re-treatment period and received treatment for an additional 16 cycles or until a discontinuation criteria was met.

Group Type: EXPERIMENTAL

ASP8374

Intervention Type: DRUG

intravenous

ASP8374 700 mg - Monotherapy Dose Escalation

Participants received ASP8374 700 mg intravenously, on day 1 of every 3 week cycle for a period of up to 16 cycles or until a discontinuation criterion was met during treatment period. Qualifying participants entered re-treatment period and received treatment for an additional 16 cycles or until a discontinuation criteria was met.

Group Type: EXPERIMENTAL

ASP8374

Intervention Type: DRUG

intravenous

ASP8374 1400 mg - Monotherapy Dose Escalation

Participants received ASP8374 1400 mg intravenously, on day 1 of every 3 week cycle for a period of up to 16 cycles or until a discontinuation criterion was met during treatment period. Qualifying participants entered re-treatment period and received treatment for an additional 16 cycles or until a discontinuation criteria was met.

Group Type: EXPERIMENTAL

ASP8374

Intervention Type: DRUG

intravenous

ASP8374 1400 mg - Monotherapy Dose Expansion

Participant received ASP8374 1400 mg intravenously, on day 1 of every 3 week cycle for a period of up to 16 cycles or until a discontinuation criterion was met during treatment period. Qualifying participants entered re-treatment period and received treatment for an additional 16 cycles or until a discontinuation criteria was met.

Group Type: EXPERIMENTAL

ASP8374

Intervention Type: DRUG

intravenous

ASP8374 20 mg - Combination Dose Escalation

Participants received ASP8374 20 mg intravenously in combination with pembrolizumab 200 mg adminstered as a 30 minutes intravenous infusion, on day 1 of every 3 week cycle for a period of up to 16 cycles or until a discontinuation criterion was met. Qualifying participants received combination treatment for an additional 16 cycles or until a discontinuation criteria was met. Participants who completed 16 cycles of combination treatment who entered the follow-up period with PR or SD were allowed to continue on pembrolizumab alone for a period of up to an additional 19 cycles. If the participant was eligible for the re-treatment period during follow up, administration of pembrolizumab alone was discontinued and combination therapy with ASP8374 was resumed per the protocol.

Group Type: EXPERIMENTAL

ASP8374

Intervention Type: DRUG

intravenous

Pembrolizumab

Intervention Type: DRUG

intravenous

ASP8374 70 mg - Combination Dose Escalation

Participants received ASP8374 70 mg intravenously in combination with pembrolizumab 200 mg adminstered as a 30 minutes intravenous infusion, on day 1 of every 3 week cycle for a period of up to 16 cycles or until a discontinuation criterion was met. Qualifying participants received combination treatment for an additional 16 cycles or until a discontinuation criteria was met. Participants who completed 16 cycles of combination treatment who entered the follow-up period with PR or SD were allowed to continue on pembrolizumab alone for a period of up to an additional 19 cycles. If the participant was eligible for the re-treatment period during follow up, administration of pembrolizumab alone was discontinued and combination therapy with ASP8374 was resumed per the protocol.

Group Type: EXPERIMENTAL

ASP8374

Intervention Type: DRUG

intravenous

Pembrolizumab

Intervention Type: DRUG

intravenous

ASP8374 200 mg - Combination Dose Escalation

Participants received ASP8374 200 mg intravenously in combination with pembrolizumab 200 mg adminstered as a 30 minutes intravenous infusion, on day 1 of every 3 week cycle for a period of up to 16 cycles or until a discontinuation criterion was met. Qualifying participants received combination treatment for an additional 16 cycles or until a discontinuation criteria was met. Participants who completed 16 cycles of combination treatment who entered the follow-up period with PR or SD were allowed to continue on pembrolizumab alone for a period of up to an additional 19 cycles. If the participant was eligible for the re-treatment period during follow up, administration of pembrolizumab alone was discontinued and combination therapy with ASP8374 was resumed per the protocol.

Group Type: EXPERIMENTAL

ASP8374

Intervention Type: DRUG

intravenous

Pembrolizumab

Intervention Type: DRUG

intravenous

ASP8374 700 mg - Combination Dose Escalation

Participants received ASP8374 700 mg intravenously in combination with pembrolizumab 200 mg adminstered as a 30 minutes intravenous infusion, on day 1 of every 3 week cycle for a period of up to 16 cycles or until a discontinuation criterion was met. Qualifying participants received combination treatment for an additional 16 cycles or until a discontinuation criteria was met. Participants who completed 16 cycles of combination treatment who entered the follow-up period with PR or SD were allowed to continue on pembrolizumab alone for a period of up to an additional 19 cycles. If the participant was eligible for the re-treatment period during follow up, administration of pembrolizumab alone was discontinued and combination therapy with ASP8374 was resumed per the protocol.

Group Type: EXPERIMENTAL

ASP8374

Intervention Type: DRUG

intravenous

Pembrolizumab

Intervention Type: DRUG

intravenous

ASP8374 1400 mg - Combination Dose Escalation

Participants received ASP8374 1400 mg intravenously in combination with pembrolizumab 200 mg adminstered as a 30 minutes intravenous infusion, on day 1 of every 3 week cycle for a period of up to 16 cycles or until a discontinuation criterion was met. Qualifying participants received combination treatment for an additional 16 cycles or until a discontinuation criteria was met. Participants who completed 16 cycles of combination treatment who entered the follow-up period with PR or SD were allowed to continue on pembrolizumab alone for a period of up to an additional 19 cycles. If the participant was eligible for the re-treatment period during follow up, administration of pembrolizumab alone was discontinued and combination therapy with ASP8374 was resumed per the protocol.

Group Type: EXPERIMENTAL

ASP8374

Intervention Type: DRUG

intravenous

Pembrolizumab

Intervention Type: DRUG

intravenous

ASP8374 200 mg - Combination Dose Expansion

Participants received ASP8374 200 mg intravenously in combination with pembrolizumab 200 mg adminstered as a 30 minutes intravenous infusion, on day 1 of every 3 week cycle for a period of up to 16 cycles or until a discontinuation criterion was met. Qualifying participants received combination treatment for an additional 16 cycles or until a discontinuation criteria was met. Participants who completed 16 cycles of combination treatment who entered the follow-up period with PR or SD were allowed to continue on pembrolizumab alone for a period of up to an additional 19 cycles. If the participant was eligible for the re-treatment period during follow up, administration of pembrolizumab alone was discontinued and combination therapy with ASP8374 was resumed per the protocol.

Group Type: EXPERIMENTAL

ASP8374

Intervention Type: DRUG

intravenous

Pembrolizumab

Intervention Type: DRUG

intravenous

ASP8374 700 mg - Combination Dose Expansion

Participants received ASP8374 700 mg intravenously in combination with pembrolizumab 200 mg adminstered as a 30 minutes intravenous infusion, on day 1 of every 3 week cycle for a period of up to 16 cycles or until a discontinuation criterion was met. Qualifying participants received combination treatment for an additional 16 cycles or until a discontinuation criteria was met. Participants who completed 16 cycles of combination treatment who entered the follow-up period with PR or SD were allowed to continue on pembrolizumab alone for a period of up to an additional 19 cycles. If the participant was eligible for the re-treatment period during follow up, administration of pembrolizumab alone was discontinued and combination therapy with ASP8374 was resumed per the protocol.

Group Type: EXPERIMENTAL

ASP8374

Intervention Type: DRUG

intravenous

Pembrolizumab

Intervention Type: DRUG

intravenous

ASP8374 1400 mg - Combination Dose Expansion

Participants received ASP8374 1400 mg intravenously in combination with pembrolizumab 200 mg adminstered as a 30 minutes intravenous infusion, on day 1 of every 3 week cycle for a period of up to 16 cycles or until a discontinuation criterion was met. Qualifying participants received combination treatment for an additional 16 cycles or until a discontinuation criteria was met. Participants who completed 16 cycles of combination treatment who entered the follow-up period with PR or SD were allowed to continue on pembrolizumab alone for a period of up to an additional 19 cycles. If the participant was eligible for the re-treatment period during follow up, administration of pembrolizumab alone was discontinued and combination therapy with ASP8374 was resumed per the protocol.

Group Type: EXPERIMENTAL

ASP8374

Intervention Type: DRUG

intravenous

Pembrolizumab

Intervention Type: DRUG

intravenous

Interventions

ASP8374

intravenous

Intervention Type: DRUG

Pembrolizumab

intravenous

Intervention Type: DRUG

Other Intervention Names

Keytruda

Eligibility Criteria

Inclusion Criteria

• Subject has locally-advanced (unresectable) or metastatic solid tumor malignancy (no limit to the number of prior treatment regimens) that is confirmed by available pathology records or current biopsy as well as:

• Subject in the escalation cohort has received all standard therapies (unless the therapy is contraindicated or intolerable) felt to provide clinical benefit for the subject's specific tumor type. OR
• Subject in an expansion cohort has received at least one standard therapy for the subject's specific tumor type.
• For Korea, Italy and Portugal only: Subject has locally-advanced (unresectable) or metastatic solid tumor malignancy (no limit to the number of prior treatment regimens) that is confirmed by available pathology records or current biopsy and has received all standard therapies (unless the therapy is contraindicated or intolerable) felt to provide clinical benefit for the subject's specific tumor type.
• Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
• Subject's last dose of prior antineoplastic therapy, including any immunotherapy, was 21 days or 5 half-lives, whichever is shorter, prior to initiation of study drug administration. A subject with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation-positive NSCLC is allowed to remain on EGFR tyrosine kinase inhibitor (TKI) therapy or ALK inhibitor until 4 days prior to the start of study drug administration.
• For Korea only: Subject's last dose of prior antineoplastic therapy, including any immunotherapy, was at least 21 days or 5 half-lives, whichever is shorter, prior to initiation of study drug administration. For drugs with a half-life greater than or equal to 21 days, the investigator should consider if this washout is sufficient. A subject with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) is allowed to remain on EGFR tyrosine kinase inhibitor (TKI) therapy until 7 days prior to the start of study drug administration.
• Subject has completed any radiotherapy (including stereotactic radiosurgery) at least 2 weeks prior to study drug administration.
• Subject's adverse events (excluding alopecia) from prior therapy have improved to grade 1 or baseline within 14 days prior to start of study treatment.
• Subject with metastatic castration resistant prostate cancer (mCRPC) (positive bone scan and/or soft tissue disease documented by computed tomography (CT) / magnetic resonance imaging (MRI)) meets both of the following:

• Subject has serum testosterone ≤ 50 ng/dL at screening.
• Subject has had an orchiectomy or plans to continue androgen deprivation therapy (ADT) for the duration of study treatment.
• Subject has adequate organ function prior to start of study treatment as indicated by the following laboratory values. If a subject has received a recent blood transfusion, the laboratory tests must be obtained ≥ 4 weeks after any blood transfusion.
• Female subject is eligible to participate if she is not pregnant and at least 1 of the following conditions applies:

• Not a woman of childbearing potential (WOCBP)
• WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 6 months after the final study drug administration.
• Female subject must agree not to breastfeed starting at screening and throughout the study treatment, and for 6 months after the final study drug administration.
• Female subject must not donate ova starting at screening and throughout the study treatment, and for 6 months after the final study drug administration.
• A male subject with female partner(s) of childbearing potential must agree to use contraception as detailed during the treatment period and for at least 6 months after the final study drug administration.
• Male subject must not donate sperm starting at screening and throughout the study treatment, and for 6 months after the final study drug administration.
• Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study treatment and for 6 months after the final study drug administration.
• Subject agrees not to participate in another interventional study while receiving study drug (subjects who are currently in the follow-up period of an interventional clinical trial are allowed).

• Subject meets one of the following:

• Subject has the tumor type for which a confirmed response was observed in a monotherapy or combination therapy dose escalation cohort; or
• For an expansion cohort opened due to achieving predicted efficacious exposure, subject has squamous cell carcinoma of the head and neck (SCCHN); or
• For tumor specific expansion cohorts of ASP8374 with pembrolizumab, subject has the applicable tumor type (e.g., non-small cell lung cancer (NSCLC), bladder cancer, gastric cancer, metastatic castration resistant prostate cancer (MCRPC) or colorectal cancer (CRC)).
• Subject has at least 1 measureable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Subjects with mCRPC who do not have measurable lesions must have at least one of the following:

• Progression with 2 or more new bone lesions; or
• Prostate-specific antigen (PSA) progression (defined as a minimum of three rising PSA levels with an interval of ≥ 1 week between each determination) within 6 weeks prior to study drug administration and a PSA value at the screening visit ≥ 2 ng/mL.
• Subject consents to provide an available tumor specimen in a tissue block or unstained serial slides obtained within 56 days prior to first dose of study treatment, or subject is an appropriate candidate for tumor biopsy and is amenable to undergoing a tumor biopsy (core needle biopsy or excision) during the screening period.This does not apply to subjects with mCRPC without measurable disease.
• Subject in any expansion cohort, is an appropriate candidate for tumor biopsy and consents to undergoing a tumor biopsy (core needle biopsy or excision) during the treatment period as indicated in the Schedule of Assessments.

Exclusion:

• Subject weighs < 45 kg at screening.
• Subject has received investigational therapy (other than an investigational epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) in a subject with EGFR activating mutations or ALK inhibitor in a subject with an ALK mutation) within 21 days or 5 half-lives, whichever is shorter, prior to start of study drug.
• Subject requires or has received systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to study drug administration. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone up to 10 mg per day of prednisone) are allowed.
• Subject has symptomatic central nervous system (CNS) metastases or subject has evidence of unstable CNS metastases even if asymptomatic (e.g., progression on scans). Subjects with previously treated CNS metastases are eligible, if subject is clinically stable and have no evidence of CNS progression by imaging for at least 4 weeks prior to start of study treatment and are not requiring immunosuppressive doses of systemic steroids (> 30 mg per day of hydrocortisone or > 10 mg per day of prednisone or equivalent) for longer than 2 weeks.
• Subject has an active autoimmune disease. Subjects with type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate replacement therapy, or skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment are allowed.
• Subject was discontinued from prior immunomodulatory therapy due to a grade ≥ 3 toxicity that was mechanistically related (e.g., immune related) to the agent.
• Subject has known history of serious hypersensitivity reaction to a known ingredient of ASP8374 or pembrolizumab or severe hypersensitivity reaction to treatment with another monoclonal antibody.
• Subject has a known history of Human Immunodeficiency Virus.
• Subject with positive for Hepatitis B virus (HBV) antibodies and surface antigen (including acute HBV or chronic HBV) or Hepatitis C ([HCV]; ribonucleic acid [RNA] detected by qualitative assay). Hepatitis C RNA testing is not required in subjects with negative Hepatitis C antibody testing.
• Subject has received a live vaccine against infectious diseases within 28 days prior to initiation of study treatment.
• Subject has a history of drug-induced pneumonitis (interstitial lung disease), a history of (non-infectious) pneumonitis that required steroids, radiation pneumonitis or currently has pneumonitis.
• Subject has an infection requiring systemic therapy within 14 days prior to study drug treatment.
• Subject has received a prior allogeneic bone marrow or solid organ transplant.
• Subject is expected to require another form of antineoplastic therapy while on study treatment.
• Subject has had a myocardial infarction or unstable angina within 6 months prior to the start of study treatment or currently has an uncontrolled illness including, but not limited to symptomatic congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Any condition that makes the subject unsuitable for study participation.
• Subject has had a major surgical procedure and has not completely recovered within 28 days prior to the start of study treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Astellas Pharma Global Development, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vice President Medical Sciences - Oncology

Role: STUDY_DIRECTOR

Astellas Pharma Global Development, Inc.

Locations

Honor Health Research Institute

Scottsdale, Arizona, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of California Los Angeles

Los Angeles, California, United States

University of California, Davis

Sacramento, California, United States

University of California, San Francisco

San Francisco, California, United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

University of Kansas Cancer Center

Fairway, Kansas, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

Columbia University Medical Center

New York, New York, United States

University Hospital of Cleveland

Cleveland, Ohio, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Mary Crowley Research Center

Dallas, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site CA15004

Edmonton, Alberta, Canada

Site CA15003

Toronto, Ontario, Canada

Site CA15001

Toronto, Ontario, Canada

Site CA15002

Montreal, Quebec, Canada

Site IT39004

Ancona, , Italy

Site IT39002

Milan, , Italy

Site IT39003

Milan, , Italy

Site IT39008

Milan, , Italy

Site IT39009

Milan, , Italy

Site IT39010

Modena, , Italy

Site IT39005

Monza, , Italy

Site IT39011

Negrar, , Italy

Site JP81001

Chūōku, , Japan

Site PT35101

Lisbon, , Portugal

Site PT35106

Porto, , Portugal

Site KR82004

Goyang-si, Gyeonggi-do, South Korea

Site KR82005

Seongnam-si, Gyeonggi-do, South Korea

Site KR82001

Seoul, , South Korea

SIte KR82002

Seoul, , South Korea

Site KR82006

Seoul, , South Korea

Site ES34002

Barcelona, , Spain

Site ES34003

Barcelona, , Spain

Site ES34009

Barcelona, , Spain

Site ES34010

Barcelona, , Spain

Site ES34001

Madrid, , Spain

Site ES34006

Madrid, , Spain

Site ES34013

Madrid, , Spain

Site ES34014

Valencia, , Spain

Site TW88602

Taichung, , Taiwan

Site TW88601

Tainan City, , Taiwan

Site TW88603

Taipei, , Taiwan

Site GB44003

London, , United Kingdom

Site GB44006

London, , United Kingdom

Site GB44004

Newcastle upon Tyne, , United Kingdom

Site GB44005

Sutton Surry, , United Kingdom

Countries

United States; Canada; Italy; Japan; Portugal; South Korea; Spain; Taiwan; United Kingdom

Related Links

https://www.clinicaltrials.astellas.com/study/8374-CL-0101/

Link to results and other applicable study documents on the Astellas Clinical Trials website

https://www.trialsummaries.com/Study/StudyDetails?id=14563&tenant=MT_AST_9011

Link to plain language summary of the study on the Trial Results Summaries website

Other Identifiers

2018-001146-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

KEYNOTE KN-A72

Identifier Type: OTHER

Identifier Source: secondary_id

8374-CL-0101

Identifier Type: -

Identifier Source: org_study_id