A Study of ASP1951 in Subjects With Advanced Solid Tumors

NCT03799003 | Terminated Phase 1 FDA Drug

• 4 other identifiers: 1951-CL-01012019-002287-27KEYNOTE-B02MK-3475-B02
• Study Type: interventional
• Target: 119
• Locations: 4 countries
• Sites: 32

Brief Summary

The primary purpose of this study is to evaluate the tolerability and safety profile of ASP1951 when administered as a single agent and in combination with pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumors; characterize the pharmacokinetic profile of ASP1951 when administered as a single agent and in combination with pembrolizumab; and determine the recommended phase 2 dose (RP2D) of ASP1951 and/or maximum tolerated dose (MTD) when administered as a single agent and in combination with pembrolizumab. This study will also evaluate the anti-tumor effect of ASP1951 when administered as a single agent and in combination with pembrolizumab.

Conditions

Advanced Solid Tumors

Keywords

ASP1951; cervical cancer; Oncology; squamous cell carcinoma of the head and neck (SCCHN); metastatic castration-resistant prostate cancer (mCRPC); melanoma; Tumors; pembrolizumab; colorectal cancer; Advanced (unresectable) or metastatic solid tumor malignancies; Advanced solid tumors

Outcome Measures

Primary Outcomes (38)

• Safety and tolerability assessed by Dose Limiting Toxicity (DLT)

  A DLT is defined as any of the prespecified Adverse Events (AEs) (graded using National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] version 4.03) that the investigator (or sponsor) cannot clearly attribute to a cause other than study drug.

  Up to 5 years

• Safety and tolerability assessed by adverse events (AEs)

  Initial and retreatment. An AE is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. AEs will be coded using the medical dictionary for regulatory activities (MedDRA) and graded using NCI-CTCAE 4.03.

  Up to 5 years

• Safety and tolerability assessed by immune-related AEs (irAEs)

  Initial and retreatment. Most frequent immune-related AEs include rash, oral mucositis, dry mouth, colitis/diarrhea, hepatitis, pneumonitis, and endocrinopathies (hypophysitis, hypothyroidism, hyperthyroidism, adrenal insufficiency and Type 1 diabetes mellitus). In the event a participant is diagnosed with an irAE, then it should be reported as an AE.

  Up to 5 years

• Safety and tolerability assessed by infusion-related reactions (IRRs)

  Initial and retreatment. IRRs are considered AEs of special interest. In the event a participant is diagnosed with an IRR, then it should be reported as an AE.

  Up to 5 years

• Safety and tolerability assessed by serious adverse events (SAEs)

  Initial and retreatment. An AE is considered "serious" if it results in any of the following outcomes: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect; requires inpatient hospitalization (except for planned procedures as allowed per study) or leads to prolongation of hospitalization (except if prolongation of planned hospitalization is not caused by an AE). Hospitalization for treatment/observation/examination caused by AE is to be considered as serious; and other medically important events.

  Up to 5 years

• Number of participants with laboratory value abnormalities and/or adverse events related to treatment

  Initial and retreatment. Number of participants with potentially clinically significant laboratory values.

  Up to 5 years

• Safety and tolerability assessed by 12- lead electrocardiogram (ECG)

  Initial and retreatment. ECGs should be obtained after the participant has rested in supine position (or semi-recumbent, if supine is not tolerated) for 10 minutes. Any clinically significant adverse changes on the ECG will be reported as AEs.

  Up to 5 years

• Number of participants with vital signs abnormalities and/or adverse events related to treatment

  Initial and retreatment. Number of participants with potentially clinically significant vital sign values.

  Up to 5 years

• Number of participants with Physical Exam abnormalities and/or adverse events related to treatment

  Initial and retreatment. Number of participants with potentially clinically significant physical exam values.

  Up to 5 years

• Safety and tolerability assessed by ECOG performance status

  Initial and retreatment. The Eastern Cooperative Oncology Group (ECOG) scale will be used to assess performance status. Grades range from 0 (fully active) to 4 (completely disabled). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.

  Up to 5 years

• Pharmacokinetics (PK) of ASP1951 in serum: AUClast

  Initial monotherapy escalation treatment only. Area under the concentration time curve from the time of dosing to the last measurable concentration (AUClast) will be recorded from the pharmacokinetic (PK) serum samples collected.

  Up to 10 weeks

• Pharmacokinetics (PK) of ASP1951 in serum: AUCinf

  Initial monotherapy escalation treatment only. Area under the concentration time curve from the time of dosing extrapolated to time infinity (AUCinf) will be recorded from the pharmacokinetic (PK) serum samples collected.

  Up to 10 weeks

• Pharmacokinetics (PK) of ASP1951 in serum: AUCinf%extrap

  Initial monotherapy escalation treatment only. Percentage of AUCinf due to extrapolation from time of the last measurable concentration to time infinity (AUCinf %extrap) will be recorded from the pharmacokinetic (PK) serum samples collected.

  Up to 10 weeks

• Pharmacokinetics (PK) of ASP1951 in serum: AUCtau

  Initial monotherapy escalation treatment only. Area under the concentration time curve from the time of dosing to the start of next dosing interval (AUCtau) will be recorded from the pharmacokinetic (PK) serum samples collected.

  Up to 10 weeks

• Pharmacokinetics (PK) of ASP1951 in serum: Cmax

  Initial monotherapy escalation treatment only. Maximum concentration (Cmax) will be recorded from the pharmacokinetic (PK) serum samples collected.

  Up to 10 weeks

• Pharmacokinetics (PK) of ASP1951 in serum: Ctrough

  Initial monotherapy escalation and retreatment. Concentration immediately prior to dosing at multiple dosing (Ctrough) will be recorded from the pharmacokinetic (PK) serum samples collected.

  Up to 48 weeks

• Pharmacokinetics (PK) of ASP1951 in serum: tmax

  Initial monotherapy escalation treatment only. Time of the maximum concentration (tmax) will be recorded from the pharmacokinetic (PK) serum samples collected.

  Up to 10 weeks

• Pharmacokinetics (PK) of ASP1951 in serum: t 1/2

  Initial monotherapy escalation treatment only. Terminal elimination half-life (t1/2) will be recorded from the pharmacokinetic (PK) serum samples collected.

  Up to 10 weeks

• Pharmacokinetics (PK) of ASP1951 in serum: tlast

  Initial monotherapy escalation treatment only. Time of last measurable concentration (tlast) will be recorded from the pharmacokinetic (PK) serum samples collected.

  Up to 10 weeks

• Pharmacokinetics (PK) of ASP1951 in serum: CL

  Initial monotherapy escalation treatment only. Total clearance after intravenous dosing (CL) will be recorded from the pharmacokinetic (PK) serum samples collected.

  Up to 10 weeks

• Pharmacokinetics (PK) of ASP1951 in serum: Vz

  Initial monotherapy escalation treatment only. Volume of distribution after intravenous dosing during the terminal elimination phase (Vz) will be recorded from the pharmacokinetic (PK) serum samples collected.

  Up to 10 weeks

• Pharmacokinetics (PK) of ASP1951 in serum: Vss

  Initial monotherapy escalation treatment only. Volume of distribution at steady state after intravenous dosing (Vss) will be recorded from the pharmacokinetic (PK) serum samples collected.

  Up to 10 weeks

• Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: AUClast

  Initial combination escalation treatment only. Area under the concentration time curve from the time of dosing to the last measurable concentration (AUClast) will be recorded from the pharmacokinetic (PK) serum samples collected.

  Up to 10 weeks

• Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: AUCinf

  Initial combination escalation treatment only. Area under the concentration time curve from the time of dosing extrapolated to time infinity (AUCinf) will be recorded from the pharmacokinetic (PK) serum samples collected.

  Up to 10 weeks

• Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: AUCinf%extrap

  Initial combination escalation treatment only. Percentage of AUCinf due to extrapolation from time of the last measurable concentration to time infinity (AUCinf %extrap) will be recorded from the pharmacokinetic (PK) serum samples collected.

  Up to 10 weeks

• Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: AUCtau

  Initial combination escalation treatment only. Area under the concentration time curve from the time of dosing to the start of next dosing interval (AUCtau) will be recorded from the pharmacokinetic (PK) serum samples collected.

  Up to 10 weeks

• Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: Cmax

  Initial combination escalation treatment only. Maximum concentration (Cmax) will be recorded from the pharmacokinetic (PK) serum samples collected.

  Up to 10 weeks

• Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: Ctrough

  Initial combination escalation and retreatment. Concentration immediately prior to dosing at multiple dosing (Ctrough) will be recorded from the pharmacokinetic (PK) serum samples collected.

  Up to 48 weeks

• Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: tmax

  Initial combination escalation treatment only. Time of the maximum concentration (tmax) will be recorded from the pharmacokinetic (PK) serum samples collected.

  Up to 10 weeks

• Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: t 1/2

  Initial combination escalation treatment only. Terminal elimination half-life (t1/2) will be recorded from the pharmacokinetic (PK) serum samples collected.

  Up to 10 weeks

• Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: tlast

  Initial combination escalation treatment only. Time of last measurable concentration (tlast) will be recorded from the pharmacokinetic (PK) serum samples collected.

  Up to 10 weeks

• Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: CL

  Initial combination escalation treatment only. Total clearance after intravenous dosing (CL) will be recorded from the pharmacokinetic (PK) serum samples collected.

  Up to 10 weeks

• Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: Vz

  Initial combination escalation treatment only. Volume of distribution after intravenous dosing during the terminal elimination phase (Vz) will be recorded from the pharmacokinetic (PK) serum samples collected.

  Up to 10 weeks

• Pharmacokinetics (PK) of ASP1951 in combination with pembrolizumab in serum: Vss

  Initial combination escalation treatment only. Volume of distribution at steady state after intravenous dosing (Vss) will be recorded from the pharmacokinetic (PK) serum samples collected.

  Up to 10 weeks

• Recommended Phase 2 Dose (RP2D) of ASP1951

  RP2D of ASP1951 as a single agent is determined using available data on safety, pharmacokinetics, pharmacodynamics and efficacy of ASP1951.

  Up to 5 years

• RP2D of ASP1951 in combination with pembrolizumab

  RP2D of ASP1951 in combination with pembrolizumab is determined using available data on safety, pharmacokinetics, pharmacodynamics and efficacy of ASP1951.

  Up to 5 years

• Maximum Tolerated Dose (MTD) of ASP1951

  MTD is defined as the dose level at which the posterior mean of DLT rate estimated using Bayesian CRM is closest but does not exceed the target DLT rate of 33%, based on the profile of DLTs collected.

  Up to 5 years

• MTD of ASP1951 in combination with pembrolizumab

  MTD is defined as the dose level at which the posterior mean of DLT rate estimated using Bayesian CRM is closest but does not exceed the target DLT rate of 33%, based on the profile of DLTs collected.

  Up to 5 years

Secondary Outcomes (4)

• Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST) V1.1 and modified RECIST 1.1 for immune-based therapeutics (iRECIST)

  Up to 5 years

• Duration of Response (DOR) per RECIST V1.1 and iRECIST

  Up to 5 years

• Persistence of response after discontinuation per RECIST V1.1 and iRECIST

  Up to 5 years

• Disease Control Rate (DCR) per RECIST V1.1 and iRECIST

  Up to 5 years

Study Arms (11)

ASP1951 0.07 mg Monotherapy

EXPERIMENTAL

Participants have received ASP1951 0.07 mg intravenously on day 1 of every 3-week cycle.

Drug: ASP1951

ASP1951 0.7 mg Monotherapy

EXPERIMENTAL

Participants have received ASP1951 0.7 mg intravenously on day 1 of every 3-week cycle.

Drug: ASP1951

ASP1951 5 mg Monotherapy

EXPERIMENTAL

Participants have received ASP1951 5 mg intravenously on day 1 of every 3-week cycle.

Drug: ASP1951

ASP1951 20 mg Monotherapy

EXPERIMENTAL

Participants have received ASP1951 20 mg intravenously on day 1 of every 3-week cycle.

Drug: ASP1951

ASP1951 70 mg Monotherapy

EXPERIMENTAL

Participants have received ASP1951 70 mg intravenously on day 1 of every 3-week cycle.

Drug: ASP1951

ASP1951 200 mg Monotherapy

EXPERIMENTAL

Participants have received ASP1951 200 mg intravenously on day 1 of every 3-week cycle.

Drug: ASP1951

ASP1951 700 mg Monotherapy

EXPERIMENTAL

Participants have received ASP1951 700 mg intravenously on day 1 of every 3-week cycle.

Drug: ASP1951

ASP1951 1400 mg Monotherapy

EXPERIMENTAL

Participants have received ASP1951 1400 mg intravenously on day 1 of every 3-week cycle.

Drug: ASP1951

ASP1951 20 mg + pembrolizumab 200 mg Combination Therapy

EXPERIMENTAL

Participants have received ASP1951 20 mg intravenously on day 1 of every 3-week cycle in combination with pembrolizumab 200 mg administered on day 1 of every 3-week cycle, at least 30 minutes after the end of infusion of ASP1951.

Drug: ASP1951; Drug: pembrolizumab

ASP1951 700 mg + pembrolizumab 200 mg Combination Therapy

EXPERIMENTAL

Participants have received ASP1951 700 mg intravenously on day 1 of every 3-week cycle in combination with pembrolizumab 200 mg administered on day 1 of every 3-week cycle, at least 30 minutes after the end of infusion of ASP1951.

Drug: ASP1951; Drug: pembrolizumab

ASP1951 1400 mg + pembrolizumab 200 mg Combination Therapy

EXPERIMENTAL

Participants have received ASP1951 1400 mg intravenously on day 1 of every 3-week cycle in combination with pembrolizumab 200 mg administered on day 1 of every 3-week cycle, at least 30 minutes after the end of infusion of ASP1951.

Drug: ASP1951; Drug: pembrolizumab

Interventions

ASP1951 DRUG

Intravenously (IV)

ASP1951 0.07 mg Monotherapy; ASP1951 0.7 mg Monotherapy; ASP1951 1400 mg + pembrolizumab 200 mg Combination Therapy; ASP1951 1400 mg Monotherapy; ASP1951 20 mg + pembrolizumab 200 mg Combination Therapy; ASP1951 20 mg Monotherapy; ASP1951 200 mg Monotherapy; ASP1951 5 mg Monotherapy; ASP1951 70 mg Monotherapy; ASP1951 700 mg + pembrolizumab 200 mg Combination Therapy; ASP1951 700 mg Monotherapy

pembrolizumab DRUG

Intravenously (IV)

Also known as: KEYTRUDA®

ASP1951 1400 mg + pembrolizumab 200 mg Combination Therapy; ASP1951 20 mg + pembrolizumab 200 mg Combination Therapy; ASP1951 700 mg + pembrolizumab 200 mg Combination Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 the following:
• Subject in the escalation cohort has received all standard therapies (unless the therapy is contraindicated or intolerable) felt to provide clinical benefit the subject's specific tumor type. OR
• Subject in an expansion cohort has received at least 1 standard therapy for the subject's specific tumor type.
• \[Taiwan only\]: 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 in the opinion of the treating investigator for his/her specific tumor type. Note: Subjects in the combination expansion cohort with tumor types that pembrolizumab is not approved for can only enroll if their standard treatment is ineffective, unsuitable per investigator's judgment or if the subject is unwilling to receive the standard therapy.
• Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• 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) or ALK inhibitor therapy until 4 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. Subjects must have recovered from all radiation related toxicities, not require corticosteroids and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to noncentral nervous system \[CNS\] disease.
• Subject's AEs (excluding alopecia) from prior therapy have improved to grade 1 or baseline within 2 weeks 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 a bilateral 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. If a subject has received a recent blood transfusion, the laboratory tests must be obtained ≥ 4 weeks after any blood transfusion. Subjects can be on stable dose of erythropoietin (≥ approximately 3 months).
• A 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); OR
• WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 6 months after the final study drug administration.

You may not qualify if:

• Subject weighs \< 45 kg.
• Subject has received investigational therapy (other than an investigational 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, 2 mg per day of dexamethasone, or up to 10 mg per day of prednisone) are allowed.
• Subject has symptomatic 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 they are 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, \> 2 mg per day of dexamethasone, or \> 10 mg per day of prednisone or equivalent) for longer than 2 weeks.
• Subject has leptomeningeal disease as a manifestation of the current malignancy.
• Subject has an active autoimmune disease that has required systemic treatment in the past 2 years. Subjects with type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate replacement therapy, and 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 (≥ grade 3) to a known ingredient of ASP1951 or pembrolizumab or severe hypersensitivity reaction to treatment with another monoclonal antibody.
• Subject with positive Hepatitis B virus (HBV) antibodies and surface antigen (indicating acute HBV or chronic HBV) or Hepatitis C (\[HCV\]; ribonucleic acid \[RNA\] detected by qualitative or quantitative assay). Hepatitis C RNA testing is not required in subjects with negative Hepatitis C antibody testing. HBV antibodies are not required in subjects with negative HBV surface antigen.
• Subject has received a live vaccine against infectious diseases within 4 weeks 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 2 weeks prior to study drug administration.
• 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.

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (32)

Arizona Clinical Research Cent

Tucson, Arizona, 85715, United States

Location

University of California

Sacramento, California, 95817, United States

Location

University of Florida, Davis C

Gainesville, Florida, 326102, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Iowa Hospitals

Iowa City, Iowa, 52242, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

Comprehensive Cancer Nevada

Las Vegas, Nevada, 89169, United States

Location

Rutgers Cancer Institute

New Brunswick, New Jersey, 08903, United States

Location

Icahn school of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Hollings Cancer Center

Charleston, South Carolina, 29425, United States

Location

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, 78229, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Multicare Regional Cancer Center Tacoma

Tacoma, Washington, 98405, United States

Location

Site CA15002

Montreal, Canada

Location

Site CA15005

Montreal, Canada

Location

Site CA15004

Ontario, Canada

Location

Site KR82002

Chungcheongbukdo, South Korea

Location

Site KR82005

Daegu, South Korea

Location

Site KR82001

Gyeonggi-do, South Korea

Location

Site KR82003

Seoul, South Korea

Location

Site KR82004

Seoul, South Korea

Location

Site KR82006

Seoul, South Korea

Location

Site KR82007

Seoul, South Korea

Location

Site TW88603

Taichung, Taiwan

Location

Site TW88604

Taipei, Taiwan

Location

Related Links

• Link to results and other applicable study documents on the Astellas Clinical Trials website
• Link to plain language summary of the study on the Trial Results Summaries website

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Neoplasms; Squamous Cell Carcinoma of Head and Neck; Melanoma; Colorectal Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Medical Monitor

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 10, 2019
• Study Start: January 14, 2019
• Primary Completion: July 6, 2023
• Study Completion: July 6, 2023
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
• Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

Locations

CA (3); US (20); KR (7); TW (2)