search
Back to results

A Study of TAK-500 With or Without Pembrolizumab in Adults With Select Locally Advanced or Metastatic Solid Tumors

Primary Purpose

Pancreatic Cancer, Hepatocellular Cancer, Mesothelioma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TAK-500
Pembrolizumab
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Drug Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  2. Individuals with the following pathologically-confirmed (cytological diagnosis is adequate) select locally advanced or metastatic solid tumors, whose disease have progressed on or are intolerant to all standard therapy: gastroesophageal (esophageal, gastroesophageal junction, and gastric) adenocarcinoma, pancreatic adenocarcinoma, hepatocellular carcinoma (HCC), nonsquamous non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), mesothelioma, and triple-negative breast cancer (TNBC). Intolerant participants are those who have developed clinical or laboratory abnormalities that prevent continued drug administration as evaluated by the principal investigator at the time of screening.
  3. Must have at least 1 RECIST version 1.1 evaluable lesion.
  4. Adequate bone marrow, renal, and hepatic functions, as determined by the following laboratory parameters:

    • Absolute neutrophil count (ANC) greater than or equal to (>=) 1000/microliter (mcL), platelet count >=75,000/mcL, and hemoglobin >= 8.0 grams per deciliter (g/dL) without growth factor support for ANC or transfusion support for platelets within 14 days before the first study treatment dose.
    • Total bilirubin <=1.5 times the institutional upper limit of normal (ULN). For participants with Gilbert's disease or HCC, <=3 milligrams per deciliter (mg/dL).
    • Serum alanine aminotransferase and aspartate aminotransferase <=3.0*ULN or <=5.0*ULN with liver metastases or HCC.
    • Albumin >=3.0 g/dL.
    • Calculated creatinine clearance using the Cockcroft-Gault formula >=30 mL/minute.
    • Left ventricular ejection fraction (LVEF) >50%, as measured by echocardiogram or multiple gated acquisition scan (MUGA) within 4 weeks before receiving the first dose of study drug.
  5. For participants with HCC only: Child-Pugh score less than or equal to 7 (Child-Pugh A or B7).
  6. Clinically significant toxic effects of previous therapy have recovered to Grade 1 (per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 5.0) or baseline, except for alopecia, Grade 2 peripheral neuropathy, and/or autoimmune endocrinopathies with stable endocrine replacement therapy.
  7. Previously treated with fully human/humanized antineoplastic monoclonal antibodies must not have received treatment with such antibodies for at least 4 weeks or the time period equal to the dosing interval, whichever is shorter. No washout period is required for prior treatment with pembrolizumab or other anti-programmed cell death protein 1 (PD-1) antibodies, although the first study dose of these drugs must not occur at an interval less than standard of care (that is, 3 weeks for 200 mg of IV pembrolizumab).

Exclusion Criteria:

  1. History of any of the following <=6 months before first dose of study drug(s): congestive heart failure New York Heart Association Grade III or IV, unstable angina, myocardial infarction, persistent hypertension >=160/100 millimeters of mercury (mmHg) despite optimal medical therapy, ongoing cardiac arrhythmias of Grade >2 (including atrial flutter/fibrillation or intermittent ventricular tachycardia), other ongoing serious cardiac conditions (example, Grade 3 pericardial effusion or Grade 3 restrictive cardiomyopathy), or symptomatic cerebrovascular events. Chronic, stable atrial fibrillation on stable anticoagulation therapy, including low molecular-weight heparin, is allowed.
  2. QT interval with Fridericia correction method >450 milliseconds (men) or >475 milliseconds (women) on a 12- lead ECG during the screening period.
  3. Grade >=2 hypotension (that is, hypotension for which nonurgent intervention is required) at screening or during C1D1 predose assessment.
  4. Oxygen saturation <92% on room air at screening or during C1D1 predose assessment.
  5. Treated with other STING agonists/antagonists, Toll-like receptor agonists or CCR2 agonist/antagonist within the past 6 months.
  6. Active vaping within 90 days of C1D1 of study drug(s).
  7. Active smoking.
  8. Active diagnosis of pneumonitis, interstitial lung disease, severe chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, other restrictive lung diseases, acute pulmonary embolism, or Grade >=2 pleural effusion not controlled by tap or requiring indwelling catheters.
  9. Grade >=2 fever of malignant origin.
  10. Chronic, active hepatitis (example, participants with known hepatitis B surface antigen seropositive and/or detectable hepatitis C virus [HCV] RNA).
  11. History of hepatic encephalopathy.
  12. Prior or current clinically significant ascites, as measured by physical examination, that requires active paracentesis for control.
  13. Treatment with any investigational products or other anticancer therapy (including chemotherapy, targeted agents, and immunotherapy), within 14 days or 5 half-lives, whichever is shorter, before C1D1 of study drug(s).
  14. Radiation therapy within 14 days (42 days for radiation to the lungs) and/or systemic treatment with radionuclides within 42 days before C1D1 of study drug(s). Participants with clinically relevant ongoing pulmonary complications from prior radiation therapy are not eligible.
  15. Use of systemic corticosteroids or other immunosuppressive therapy, concurrently or within 14 days of C1D1 of study drug(s), with the following exceptions:

    • Topical, intranasal, inhaled, ocular, and/or intra-articular corticosteroids.
    • Physiological doses of replacement steroid therapy (example, for adrenal insufficiency), not to exceed the equivalent of 10 mg prednisone daily.
  16. Recipients of allogeneic or autologous stem cell transplantation or organ transplantation.

Additional criteria specific for participants in TAK-500 and pembrolizumab combination arm only:

  1. Contraindication to the administration of a pembrolizumab or prior intolerance to pembrolizumab or other anti-PD-1 or anti-programmed cell death-ligand 1 antibody.
  2. History of intolerance to any component of the trial treatment agents or known serious or severe hypersensitivity reaction to any of the study drugs or their excipients. (Pembrolizumab is formulated with L-histidine, polysorbate 80, and sucrose,

Sites / Locations

  • City of HopeRecruiting
  • University of California San Diego
  • University of Colorado - Anschutz Medical Campus - PPDSRecruiting
  • Sarah Cannon Research InstituteRecruiting
  • Dana Farber Cancer InstituteRecruiting
  • Fox Chase Cancer CenterRecruiting
  • START South Texas Accelerated Research TherapeuticsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Dose Escalation: TAK-500 Single Agent (SA) (dosed Q3W or Q2W)

Dose Escalation: TAK-500 (dosed Q3W) + Pembrolizumab (dosed Q3W)

Dose Expansion: TAK-500 (dosed Q3W and/or Q2W) + Pembrolizumab (dosed Q3W)

Arm Description

TAK-500 dose escalation starting at 8 microgram per kilogram (mcg/kg), infusion, intravenously, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) or once on Day 1, 15 and 29 of each 42-day treatment cycle (every 2 weeks, Q2W), for up to 1 year.

TAK-500, infusion, intravenously, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) or once on Day 1, 15 and 29 of each 42-day treatment cycle (once every 2 weeks, Q2W), for up to 1 year, along with pembrolizumab 200 milligram (mg) infusion, intravenously, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year. The exact starting dose of TAK-500 will be determined from the results of the TAK-500 SA arm dose escalation.

TAK-500, infusion, intravenously, once on Days 1 and 22 (Q3W), or once on Days 1, 15, and 29, in a 42-day treatment cycle (once every 2 weeks, Q2W) with pembrolizumab 200 mg infusion, intravenously, once on Days 1 and 22, in a 42-day treatment cycle (Q3W) for up to 1 year. The dose of TAK-500 for the Dose Expansion arm will be based on the results of the TAK-500 in combination with pembrolizumab Dose Escalation arm.

Outcomes

Primary Outcome Measures

Number of Participants With Grade 3 or Higher TEAEs
TEAE Grades will be evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)
Number of Participants With Dose Limiting Toxicities (DLTs)
DLT will be defined as any of the TEAEs that occur during Cycle 1 and are considered by the investigator to be at least possibly related to TAK-500 as a SA or in combination with pembrolizumab. Toxicity will be evaluated according to NCI CTCAE version 5.0.
Number of Participants Reporting one or More Serious Adverse Event (SAEs)
Number of Participants With one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations

Secondary Outcome Measures

Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAK-500
AUCt: Area Under the Serum Concentration-time Curve From Time 0 to Time t for TAK-500
AUCinf: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-500
t1/2: Terminal Disposition Phase Half-life for TAK-500
CL: Total Clearance After Intravenous Administration for TAK-500
Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-500
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who achieve cPR or cCR (determined by the investigator) during the study in the response-evaluable population. ORR will be assessed as per RECIST Version 1.1. CR: defined as disappearance of all target and non- target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than <10 mm. PR: defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. cPR or cCR is defined as a PR or CR that is confirmed with additional imaging 6 weeks after initial response.
Disease Control Rate (DCR)
DCR is defined as the percentage of participants who achieve cCR + cPR + stable disease (SD) or better (determined by the investigator) greater than (>) 6 weeks during the study in the response-evaluable population. DCR will be assessed as per RECIST Version 1.1. CR: disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: at least a 20% increase in the sum of diameters of target lesions.
Duration of Response (DOR)
DOR is defined as the time from the date of first documentation of a cPR or better to the date of first documentation of PD for responders (cPR or better). Responders without documentation of PD will be censored at the date of last response assessment that is SD or better. DOR will be assessed as per RECIST Version 1.1. PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: at least a 20% increase in the sum of diameters of target lesions.
Time to Response (TTR)
TTR is defined as the time from the date of first dose administration to the date of first documented cPR or better (determined by the investigator) in the safety population. TTR will be assessed as per RECIST Version 1.1. PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.
Dose Expansion: Progression Free Survival (PFS)
PFS is defined as the time from date of study treatment to the first documented PD based on RECIST v.1.1, or death due to any cause, whichever occurs first. PD: at least a 20% increase in the sum of diameters of target lesions.
Changes in Intratumoral Tumor Cell Infiltration
Measurement of changes in tumor immune cell infiltration will be measured by immunohistochemistry or in-situ hybridization on fresh tumor biopsies taken pre and post treatment (up to 23 days after first administration of TAK-500) for each participant.
Number of Participants With Positive Anti-drug Antibody (ADA) and Acquired Immunogenicity

Full Information

First Posted
September 24, 2021
Last Updated
January 17, 2023
Sponsor
Takeda
search

1. Study Identification

Unique Protocol Identification Number
NCT05070247
Brief Title
A Study of TAK-500 With or Without Pembrolizumab in Adults With Select Locally Advanced or Metastatic Solid Tumors
Official Title
An Open-label, Dose Escalation and Expansion, Phase 1a/1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-500, a Novel Stimulator of Interferon Genes Agonist, as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Select Locally Advanced or Metastatic Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2022 (Actual)
Primary Completion Date
March 20, 2025 (Anticipated)
Study Completion Date
March 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is about TAK-500, given either alone or with pembrolizumab, in adults with select locally advanced or metastatic solid tumors. The aims of the study are: to assess the safety profile of TAK-500 when given alone and when given with pembrolizumab. to assess the effects of TAK-500, when given alone and when given with pembrolizumab, on adults with locally advanced or metastatic solid tumors. Participants may receive TAK-500 for up to 1 year. Participants may continue with their treatment if they have continuing benefit and if this is approved by their study doctor. Participants who are receiving TAK-500 either alone or with pembrolizumab will continue with their treatment until their disease progresses or until they or their study doctor decide they should stop this treatment.
Detailed Description
The drug being tested in this study is called TAK-500. The study will evaluate the safety, tolerability, antitumor activity, pharmacokinetics (PK), and pharmacodynamics of TAK-500 when used as a single agent (SA) and in combination with pembrolizumab in participants with locally advanced or metastatic solid tumors. The study will be conducted in 2 phases: Dose Escalation and Dose Expansion Phase. The study will enroll approximately 118 participants (approximately 84 in the Dose Escalation Phase and approximately 34 in Dose Expansion Phase). The dose escalation phase will determine the recommended dose of TAK-500 along with the combination agents for the dose expansion phase. All the participants will be assigned to one of the 3 cohorts: TAK-500 Single Agent (SA) (dosed Q3W or Q2W) Dose Escalation: TAK-500 (dosed Q3W or Q2W) + Pembrolizumab (dosed Q3W) Dose Expansion: TAK-500 (dosed Q3W and/or Q2W) + Pembrolizumab (dosed Q3W) This multi-center trial will be conducted in the United States. Participants with demonstrated clinical benefit may continue treatment beyond 1 year if approved by the sponsor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Hepatocellular Cancer, Mesothelioma, Breast Cancer, Gastric Cancer, Esophageal Cancer, Nasopharyngeal Cancer, Kidney Cancer, Squamous Cell Cancer of Head and Neck (SCCHN), Non-small Cell Lung Cancer (NSCLC), Non-squamous
Keywords
Drug Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation: TAK-500 Single Agent (SA) (dosed Q3W or Q2W)
Arm Type
Experimental
Arm Description
TAK-500 dose escalation starting at 8 microgram per kilogram (mcg/kg), infusion, intravenously, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) or once on Day 1, 15 and 29 of each 42-day treatment cycle (every 2 weeks, Q2W), for up to 1 year.
Arm Title
Dose Escalation: TAK-500 (dosed Q3W) + Pembrolizumab (dosed Q3W)
Arm Type
Experimental
Arm Description
TAK-500, infusion, intravenously, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) or once on Day 1, 15 and 29 of each 42-day treatment cycle (once every 2 weeks, Q2W), for up to 1 year, along with pembrolizumab 200 milligram (mg) infusion, intravenously, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year. The exact starting dose of TAK-500 will be determined from the results of the TAK-500 SA arm dose escalation.
Arm Title
Dose Expansion: TAK-500 (dosed Q3W and/or Q2W) + Pembrolizumab (dosed Q3W)
Arm Type
Experimental
Arm Description
TAK-500, infusion, intravenously, once on Days 1 and 22 (Q3W), or once on Days 1, 15, and 29, in a 42-day treatment cycle (once every 2 weeks, Q2W) with pembrolizumab 200 mg infusion, intravenously, once on Days 1 and 22, in a 42-day treatment cycle (Q3W) for up to 1 year. The dose of TAK-500 for the Dose Expansion arm will be based on the results of the TAK-500 in combination with pembrolizumab Dose Escalation arm.
Intervention Type
Drug
Intervention Name(s)
TAK-500
Intervention Description
TAK-500 intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Pembrolizumab intravenous infusion.
Primary Outcome Measure Information:
Title
Number of Participants With Grade 3 or Higher TEAEs
Description
TEAE Grades will be evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
Time Frame
Up to 30 months
Title
Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)
Time Frame
Up to 30 months
Title
Number of Participants With Dose Limiting Toxicities (DLTs)
Description
DLT will be defined as any of the TEAEs that occur during Cycle 1 and are considered by the investigator to be at least possibly related to TAK-500 as a SA or in combination with pembrolizumab. Toxicity will be evaluated according to NCI CTCAE version 5.0.
Time Frame
Up to 30 months
Title
Number of Participants Reporting one or More Serious Adverse Event (SAEs)
Time Frame
Up to 30 months
Title
Number of Participants With one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations
Time Frame
Up to 30 months
Secondary Outcome Measure Information:
Title
Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAK-500
Time Frame
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 4 Day 1: pre-infusion and at multiple time points (up to 21 days) post-infusion (Cycle length=21 days)
Title
AUCt: Area Under the Serum Concentration-time Curve From Time 0 to Time t for TAK-500
Time Frame
Cycle 1 Day 1, and Cycle 2 Day 1: pre-infusion and at multiple time points (up to 21 days) post-infusion (Cycle length=21 days)
Title
AUCinf: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-500
Time Frame
Cycle 1 Day 1, and Cycle 2 Day 1: pre-infusion and at multiple time points (up to 21 days) post-infusion (Cycle length=21 days)
Title
t1/2: Terminal Disposition Phase Half-life for TAK-500
Time Frame
Cycle 1 Day 1, and Cycle 2 Day 1: pre-infusion and at multiple time points (up to 21 days) post-infusion (Cycle length=21 days)
Title
CL: Total Clearance After Intravenous Administration for TAK-500
Time Frame
Cycle 1 Day 1, and Cycle 2 Day 1: pre-infusion and at multiple time points (up to 21 days) post-infusion (Cycle length=21 days)
Title
Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-500
Time Frame
Cycle 1 Day 1, and Cycle 2 Day 1: pre-infusion and at multiple time points (up to 21 days) post-infusion (Cycle length=21 days)
Title
Overall Response Rate (ORR)
Description
ORR is defined as the percentage of participants who achieve cPR or cCR (determined by the investigator) during the study in the response-evaluable population. ORR will be assessed as per RECIST Version 1.1. CR: defined as disappearance of all target and non- target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than <10 mm. PR: defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. cPR or cCR is defined as a PR or CR that is confirmed with additional imaging 6 weeks after initial response.
Time Frame
Up to 30 months
Title
Disease Control Rate (DCR)
Description
DCR is defined as the percentage of participants who achieve cCR + cPR + stable disease (SD) or better (determined by the investigator) greater than (>) 6 weeks during the study in the response-evaluable population. DCR will be assessed as per RECIST Version 1.1. CR: disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: at least a 20% increase in the sum of diameters of target lesions.
Time Frame
Up to 30 months
Title
Duration of Response (DOR)
Description
DOR is defined as the time from the date of first documentation of a cPR or better to the date of first documentation of PD for responders (cPR or better). Responders without documentation of PD will be censored at the date of last response assessment that is SD or better. DOR will be assessed as per RECIST Version 1.1. PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: at least a 20% increase in the sum of diameters of target lesions.
Time Frame
Up to 30 months
Title
Time to Response (TTR)
Description
TTR is defined as the time from the date of first dose administration to the date of first documented cPR or better (determined by the investigator) in the safety population. TTR will be assessed as per RECIST Version 1.1. PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.
Time Frame
Up to 30 months
Title
Dose Expansion: Progression Free Survival (PFS)
Description
PFS is defined as the time from date of study treatment to the first documented PD based on RECIST v.1.1, or death due to any cause, whichever occurs first. PD: at least a 20% increase in the sum of diameters of target lesions.
Time Frame
Up to 30 months
Title
Changes in Intratumoral Tumor Cell Infiltration
Description
Measurement of changes in tumor immune cell infiltration will be measured by immunohistochemistry or in-situ hybridization on fresh tumor biopsies taken pre and post treatment (up to 23 days after first administration of TAK-500) for each participant.
Time Frame
Up to 23 days after first administration of TAK-500
Title
Number of Participants With Positive Anti-drug Antibody (ADA) and Acquired Immunogenicity
Time Frame
Up to 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. Individuals with the following pathologically confirmed (cytological diagnosis is adequate) select locally advanced or metastatic solid tumors, whose disease has progressed on or are intolerant to all standard therapy: gastroesophageal (esophageal, gastroesophageal junction, and gastric) adenocarcinoma, pancreatic adenocarcinoma, hepatocellular carcinoma (HCC), nonsquamous non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), mesothelioma, triple-negative breast cancer (TNBC), renal clear cell carcinoma (RCC) and nasopharyngeal carcinoma (NPC). Participants who are intolerant to all standard therapies are those who have developed clinical or laboratory abnormalities that prevent continued drug administration as evaluated by the principal investigator at the time of screening. Must have at least 1 RECIST version 1.1 measurable lesion. Adequate bone marrow, renal, and hepatic functions, as determined by the following laboratory parameters: Absolute neutrophil count (ANC) greater than or equal to (>=) 1000/microliter (mcL), platelet count >=75,000/mcL, and hemoglobin >= 8.0 grams per deciliter (g/dL) without growth factor support for ANC or transfusion support for platelets within 14 days before the first study treatment dose. Total bilirubin <=1.5 times the institutional upper limit of normal (ULN). For participants with Gilbert's disease or HCC, <=3 milligrams per deciliter (mg/dL). Serum alanine aminotransferase and aspartate aminotransferase <=3.0*ULN or <=5.0*ULN with liver metastases or HCC. Albumin >=3.0 g/dL. Calculated creatinine clearance using the Cockcroft-Gault formula >=30 mL/minute. Left ventricular ejection fraction (LVEF) >50%, as measured by echocardiogram or multiple gated acquisition scan (MUGA) within 4 weeks before receiving the first dose of study drug. For participants with HCC only: Child-Pugh score less than or equal to 7 (Child-Pugh A or B7). Clinically significant toxic effects of previous therapy have recovered to Grade 1 (per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 5.0) or baseline, except for alopecia, Grade 2 peripheral neuropathy, and/or autoimmune endocrinopathies with stable endocrine replacement therapy. Previously treated with fully human/humanized antineoplastic monoclonal antibodies must not have received treatment with such antibodies for at least 4 weeks or the time period equal to the dosing interval, whichever is shorter. No washout period is required for prior treatment with pembrolizumab or other anti-programmed cell death protein 1 (PD-1) antibodies, although the first study dose of these drugs must not occur at an interval less than standard of care (that is, 3 weeks for 200 mg of IV pembrolizumab). Exclusion Criteria: History of any of the following <=6 months before first dose of study drug(s): congestive heart failure New York Heart Association Grade III or IV, unstable angina, myocardial infarction, persistent hypertension >=160/100 millimeters of mercury (mmHg) despite optimal medical therapy, ongoing cardiac arrhythmias of Grade >2 (including atrial flutter/fibrillation or intermittent ventricular tachycardia), other ongoing serious cardiac conditions (example, Grade 3 pericardial effusion or Grade 3 restrictive cardiomyopathy), or symptomatic cerebrovascular events. Chronic, stable atrial fibrillation on stable anticoagulation therapy, including low molecular-weight heparin, is allowed. QT interval with Fridericia correction method >450 milliseconds (men) or >475 milliseconds (women) on a 12- lead ECG during the screening period. Grade >=2 hypotension (that is, hypotension for which nonurgent intervention is required) at screening or during C1D1 predose assessment. Oxygen saturation <92% on room air at screening or during C1D1 predose assessment. Treatment with other STING agonists/antagonists, Toll-like receptor agonists or CCR2 agonist/antagonist within the past 6 months. Active vaping within 90 days of C1D1 of study drug(s). Active smoking. Active diagnosis of pneumonitis, interstitial lung disease, severe chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, other restrictive lung diseases, acute pulmonary embolism, or Grade >=2 pleural effusion not controlled by tap or requiring indwelling catheters. Grade >=2 fever of malignant origin. Chronic, active hepatitis (example, participants with known hepatitis B surface antigen seropositive and/or detectable hepatitis C virus [HCV] RNA). History of hepatic encephalopathy. Prior or current clinically significant ascites, as measured by physical examination, that requires active paracentesis for control. Treatment with any investigational products or other anticancer therapy (including chemotherapy, targeted agents, and immunotherapy), within 14 days or 5 half-lives, whichever is shorter, before C1D1 of study drug(s). Radiation therapy within 14 days (42 days for radiation to the lungs) and/or systemic treatment with radionuclides within 42 days before C1D1 of study drug(s). Participants with clinically relevant ongoing pulmonary complications from prior radiation therapy are not eligible. Use of systemic corticosteroids or other immunosuppressive therapy, concurrently or within 14 days of C1D1 of study drug(s), with the following exceptions: Topical, intranasal, inhaled, ocular, intra-articular, and/or other nonsystemic corticosteroids. Physiological doses of replacement steroid therapy (example, for adrenal insufficiency), not to exceed the equivalent of 10 mg prednisone daily. Recipients of allogeneic or autologous stem cell transplantation or organ transplantation. Additional criteria specific for participants in TAK-500 and pembrolizumab combination arm only: Contraindication to the administration of a pembrolizumab or prior intolerance to pembrolizumab or other anti-PD-1 or anti-programmed cell death protein ligand 1 antibody. History of intolerance to any component of the study treatment agents or known serious or severe hypersensitivity reaction to any of the study drugs or their excipients. (Pembrolizumab is formulated with L-histidine, polysorbate 80, and sucrose
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Takeda Contact
Phone
+1-877-825-3327
Email
medinfoUS@takeda.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
626-256-9200
Email
vchung@coh.org
First Name & Middle Initial & Last Name & Degree
Vincent Chung
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-1503
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
858-822-5354
Email
spatel@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Sandip Patel
Facility Name
University of Colorado - Anschutz Medical Campus - PPDS
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
303-724-5499
Email
jennifer.diamond@ucdenver.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Diamond
Facility Name
Sarah Cannon Research Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218-1238
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
720-754-4653
Email
jason.henry2@sarahcannon.com
First Name & Middle Initial & Last Name & Degree
Jason Henry
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5418
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
617-632-3000
Email
harshabad_singh@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Singh Harshabad
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2434
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
215-214-1676
Email
anthony.olszanski@fccc.edu
First Name & Middle Initial & Last Name & Degree
Anthony Olszanski
Facility Name
START South Texas Accelerated Research Therapeutics
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3307
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
210-593-5265
Email
drew.rasco@startsa.com
First Name & Middle Initial & Last Name & Degree
Drew Rasco

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing URL
https://vivli.org/ourmember/takeda/
Links:
URL
https://clinicaltrials.takeda.com/study-detail/cd7f62bc11ed4790?idFilter=%5B%22TAK-500-1001%22%5D
Description
To obtain more information on the study, click here/on this link

Learn more about this trial

A Study of TAK-500 With or Without Pembrolizumab in Adults With Select Locally Advanced or Metastatic Solid Tumors

We'll reach out to this number within 24 hrs