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A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers

Primary Purpose

Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Squamous Cell Carcinoma of Head and Neck

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pembrolizumab
TAK-676
Image-guided radiation therapy
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung 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. Participants must have at least 2 measurable lesions (i.e. ≥10 mm longest diameter for extranodal lesions, ≥15 mm short axis for lymph nodes), with at least one inside and at least one other outside of the radiation field. The tumor outside the radiation field must be accessible for biopsy, and the participant must consent to tumor biopsy at screening and during treatment.
  3. Participants must have pathologically confirmed (cytological diagnosis is adequate) advanced or metastatic NSCLC, TNBC, or SCCHN who have:

    • Received or been offered all established standard of care (SOC) treatment options for which they are eligible; and
    • Progressed on CPIs in a prior line of therapy.
  4. Adequate bone marrow, renal and hepatic functions.
  5. Left ventricular ejection fraction (LVEF) >50%, as measured by echocardiogram or multiple-gated acquisition (MUGA) scan within 4 weeks before receiving the first dose of study drug.
  6. Clinically significant toxic effects of previous therapy have recovered to Grade 1 (per NCI CTCAE, V5.0) or baseline, except for alopecia, Grade 2 peripheral neuropathy, and/or autoimmune endocrinopathies with stable endocrine replacement therapy.

Exclusion Criteria:

  1. History of any serious cardiac or cerebrovascular conditions in the last 6 months, including uncontrolled congestive heart disease, unstable angina, myocardial infarction, hypertension greater than or equal to (≥) 160/100 millimeter of mercury (mmHg) in spite of optimal therapy, cardiac arrhythmias, pericardial effusion, cardiomyopathy, or symptomatic stroke. Chronic, stable atrial fibrillation on stable anticoagulation therapy, including low molecular weight heparin, will be allowed.
  2. History of brain metastasis unless:

    • Clinically stable, (that is, treatment completed ≥4 weeks prior) following prior surgery, whole-brain radiation, or stereotactic radiosurgery, AND
    • Off corticosteroids.
  3. Known history of uncontrolled autoimmune disorders, human immunodeficiency virus (HIV) infection, or other relevant congenital or acquired immunodeficiencies.
  4. Chronic, active hepatitis (example, participants with known hepatitis B surface antigen seropositive and/or detectable hepatitis C virus [HCV]-ribonucleic acid [RNA]).
  5. Treatment with any investigational products and systemic anticancer drugs (including vascular endothelial growth factor (VEGF) inhibitors), within 14 days or 5 half-lives, whichever is shorter, before Cycle 1 Day 1 (C1D1) of study drugs.
  6. Prior radiation to lesions chosen for biopsy or response assessment.
  7. Prior radiation to lesions other than those chosen for radiation therapy or biopsy in the current protocol within 4 weeks of C1D1 of study drug(s).
  8. Use of systemic corticosteroids or other immunosuppressive therapy, concurrently or within 7 days of start of radiation therapy, 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).
  9. Receipt of live attenuated vaccine (example, tuberculosis Bacillus Calmette-guerin [BCG] vaccine, oral polio vaccine, measles, rotavirus, yellow fiver) within 28 days of C1D1 of study drug(s).
  10. Recipients of allogeneic or autologous stem cell transplantation or organ transplantation.
  11. Ongoing Grade ≥2 infection or participants with Grade ≥2 fever of malignant origin.
  12. Fridericia's corrected QT interval (QTcF) >450 milliseconds (msec) (males) or >475 msec (females) on a 12-lead electrocardiogram (ECG) during the screening period.
  13. Grade ≥2 hypotension (that is, hypotension for which nonurgent intervention is required) at screening or during C1D1 pre-dose assessment.
  14. Oxygen saturation less than (<) 92% on room air at screening or during C1D1 predose assessment.
  15. Use of medications that are known clinical organic anion transporting polypeptide 1B1 (OATP1B1) and/or OATP1B3 inhibitors, concurrently or within 14 days of C1D1 of study drugs.
  16. Current smoker.
  17. Vaping within 90 days of C1D1 of study drugs.
  18. Current diagnosis of pneumonitis, interstitial lung disease, severe chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis, other restrictive lung diseases, acute pulmonary embolism, or Grade ≥2 pleural effusion or ascites not controlled by tap or requiring indwelling catheters.
  19. Treated with other stimulator of interferon genes (STING) agonists/antagonist and toll-like receptors agonists within the past 6 months.

Sites / Locations

  • Cedars Sinai Medical CenterRecruiting
  • University of ChicagoRecruiting
  • Laura And Isaac Perlmutter Cancer CenterRecruiting
  • Providence Portland Medical CenterRecruiting
  • University of Pittsburgh Medical Center
  • Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combination Dose Escalation Phase: Radiation + Pembrolizumab + TAK-676

Arm Description

Participants will receive image-guided radiation therapy between Day -8 and Day -2. Participants will then receive pembrolizumab 200 milligram (mg), infusion, intravenously (IV), once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by TAK-676 infusion with escalating doses (0.2 mg and above), IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurs first.

Outcomes

Primary Outcome Measures

Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Based on TEAEs Severity
AE: any untoward medical occurrence in participants administered with pharmaceutical product that does not necessarily have a causal relationship with this treatment. TEAE: any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug is considered treatment emergent. Severity grade is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Grade 1: Mild (asymptomatic/mild symptoms; clinical/diagnostic observations only; intervention not indicated); Grade 2: Moderate (minimal, local/noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living [ADL]); Grade 3: Severe (severe/medically significant but not immediately life-threatening hospitalization/prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death related to AE.
Number of Participants with Dose-limiting Toxicities (DLTs)
A DLT is defined as any TEAE that occur during Cycle 1 and is considered by investigator to be at least possibly related to TAK-676 in combination with pembrolizumab. TEAEs meeting DLT definitions occurring in later cycles will be considered in the determination of RP2D of TAK-676. DLTs will be assessed based on NCI CTCAE version 5.0.
Number of Participants Reporting One or More Treatment Emergent Serious Adverse events (TESAEs)
TEAE: any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug is considered treatment emergent. An SAE is defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is a medically important event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization
Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuation
TEAE: any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug is considered treatment emergent.

Secondary Outcome Measures

Overall Response Rate (ORR) Assessed by Investigator as per RECIST v1.1
ORR will be defined as the percentage of participants who achieve confirmed complete response (cCR) or confirmed partial response (cPR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version1.1 (RECIST, V1.1).
Duration of Response (DOR) For all Tumor Lesions Assessed by Investigator as per RECIST v1.1
DOR will be defined as 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 stable disease (SD) or better. Evaluation will be determined by the investigator according to RECIST, V1.1.
Time to Response (TTR) For all Tumor Lesions Assessed by Investigator as per RECIST v1.1
TTR will be defined as the time from the date of first dose administration to the date of first documented cPR or better as determined by the investigator according to RECIST, V1.1.
Overall Response Rate Assessed by Investigator as per Modified Intratumoral Immunotherapy RECIST (modified itRECIST)
ORR will be defined as the percentage of participants who achieve confirmed complete response (cCR) or confirmed partial response (cPR) as determined by the investigator according to Modified itRECIST.
Overall Response Rate For Tumors Within the Radiation Field (ORRirradiated)
ORRirradiated will be defined as the percentage of participants who achieve cCRirradiated or cPRirradiated in the tumor lesions lying within the radiation field as determined by the investigator according to modified itRECIST.
Overall Response Rate For Tumors Outside the Radiation Field (ORRnonirradiated)
ORRnonirradiated will be defined as the percentage of participants who achieve cCRnonirradiated or cPRnonirradiated in the tumor lesions lying outside of the radiation field as determined by the investigator according to modified itRECIST.
Duration of Response (DOR) For Tumors Within the Radiation Field (DORirradiated)
DORirradiated for tumor lesions lying within radiation field will be defined as the time from the date of first documentation of a cPRirradiated or better to the date of first documentation of irradiated PD in those lesions for irradiated responders (cPRirradiated or better). Irradiated responders without documentation of irradiated PD will be censored at the date of last response assessment that is irradiated SD or better. Evaluation will be determined by the investigator according to modified itRECIST.
Duration of Response (DOR) For Tumors Outside the Radiation Field (DORnonirradiated)
DORnonirradiated for tumor lesions lying outside of the radiation field will be defined as time from the date of first documentation of a cPRnonirradiated or better to the date of first documentation of nonirradiated PD in those lesions for nonirradiated responders (cPRnonirradiated or better). Nonirradiated responders without documentation of nonirradiated PD will be censored at the date of last response assessment that is nonirradiated SD or better. Evaluation will be determined by the investigator according to modified itRECIST.
Time to Response (TTR) For Tumors Within the Radiation Field (TTRirradiated)
TTRirradiated in the tumor lesions lying within the radiation field will be defined as the time from the date of first dose administration to the date of first documented cPRirradiated or better as determined by the investigator according to modified itRECIST.
Time to Response (TTR) For Tumors Outside the Radiation Field (TTRnonirradiated)
TTRnonirradiated in the tumor lesions lying outside of the radiation field will be defined as the time from the date of first dose administration to the date of first documented cPRnonirradiated or better during the study in response-evaluable population as determined by the investigator according to modified itRECIST.
Number of Participants with Increase in T-Cell Infiltration in Tumor Evaluated by Immunohistochemistry
Participants with the increase in T-cell infiltration levels between the pretreatment and on-treatment tumor biopsies will be reported.

Full Information

First Posted
May 7, 2021
Last Updated
August 31, 2023
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT04879849
Brief Title
A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers
Official Title
An Open-label, Phase 1, Dose-escalation Study to Evaluate the Safety and Preliminary Antitumor Activity of TAK-676 With Pembrolizumab Following Radiation Therapy in the Treatment of Non-small-cell Lung Cancer, Triple-negative Breast Cancer, or Squamous-cell Carcinoma of the Head and Neck That Has Progressed on Checkpoint Inhibitors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2021 (Actual)
Primary Completion Date
February 18, 2024 (Anticipated)
Study Completion Date
February 18, 2024 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study, adults with non-small-cell lung cancer (NSCLC), triple-negative breast cancer (TNBC) and squamous-cell carcinoma of the head and neck (SCCHN) will be treated with TAK-676 and pembrolizumab following radiotherapy. The main aims of this study are to check if people are improving after treatment with TAK-676, getting side effects from these combined treatments, and how much TAK-676 people with these cancers can receive without getting unacceptable side effects from it. Participants will receive radiotherapy, then at least 40 hours later will receive pembrolizumab followed by TAK-676 slowly through a vein (infusion). Participants will receive an infusion of pembrolizumab at the same dose every 3 weeks. Different small groups of participants will receive lower to higher doses of TAK-676 on specific days of a 21-day cycle. This study will be happening at sites in North America.
Detailed Description
The drug being tested in this study is called TAK-676. This study will evaluate the safety, tolerability and preliminary antitumor activity of TAK-676 with pembrolizumab following radiation therapy in the treatment of advanced NSCLC, TNBC or SCCHN that has progressed on checkpoint inhibitors (CPIs) and will estimate the maximum tolerated dose (MTD) and determine the recommended phase 2 dose (RP2D) of this combination. The study will enroll approximately 65 participants. Participants will be assigned to dose escalating cohorts based on Bayesian Optimal Interval (BOIN) design. The starting dose of TAK-676 will be 0.2 mg and the subsequent dosing will be initiated based on the available safety and tolerability data from the previous cohort. This multi-center trial will be conducted in the United States. There will be many clinic visits. The number of visits will depend on the number of cycles of treatment. Participants will attend an end of treatment (EOT) visit 30 days after receiving their last dose of study drug or before the start of subsequent systemic anticancer therapy, whichever occurs first. They might continue to have check-ups every 12 weeks if they left the study for a reason apart from their cancer getting worse.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Squamous Cell Carcinoma of Head and Neck
Keywords
Drug Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combination Dose Escalation Phase: Radiation + Pembrolizumab + TAK-676
Arm Type
Experimental
Arm Description
Participants will receive image-guided radiation therapy between Day -8 and Day -2. Participants will then receive pembrolizumab 200 milligram (mg), infusion, intravenously (IV), once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by TAK-676 infusion with escalating doses (0.2 mg and above), IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurs first.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
IV infusion.
Intervention Type
Drug
Intervention Name(s)
TAK-676
Intervention Description
IV infusion.
Intervention Type
Radiation
Intervention Name(s)
Image-guided radiation therapy
Intervention Description
Radiation therapy.
Primary Outcome Measure Information:
Title
Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Based on TEAEs Severity
Description
AE: any untoward medical occurrence in participants administered with pharmaceutical product that does not necessarily have a causal relationship with this treatment. TEAE: any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug is considered treatment emergent. Severity grade is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Grade 1: Mild (asymptomatic/mild symptoms; clinical/diagnostic observations only; intervention not indicated); Grade 2: Moderate (minimal, local/noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living [ADL]); Grade 3: Severe (severe/medically significant but not immediately life-threatening hospitalization/prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death related to AE.
Time Frame
From first dose of study drug administration up to 30 months
Title
Number of Participants with Dose-limiting Toxicities (DLTs)
Description
A DLT is defined as any TEAE that occur during Cycle 1 and is considered by investigator to be at least possibly related to TAK-676 in combination with pembrolizumab. TEAEs meeting DLT definitions occurring in later cycles will be considered in the determination of RP2D of TAK-676. DLTs will be assessed based on NCI CTCAE version 5.0.
Time Frame
Up to 30 months
Title
Number of Participants Reporting One or More Treatment Emergent Serious Adverse events (TESAEs)
Description
TEAE: any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug is considered treatment emergent. An SAE is defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is a medically important event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization
Time Frame
From first dose of study drug administration up to 30 months
Title
Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuation
Description
TEAE: any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug is considered treatment emergent.
Time Frame
From first dose of study drug administration up to 30 months
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR) Assessed by Investigator as per RECIST v1.1
Description
ORR will be defined as the percentage of participants who achieve confirmed complete response (cCR) or confirmed partial response (cPR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version1.1 (RECIST, V1.1).
Time Frame
Up to 30 months
Title
Duration of Response (DOR) For all Tumor Lesions Assessed by Investigator as per RECIST v1.1
Description
DOR will be defined as 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 stable disease (SD) or better. Evaluation will be determined by the investigator according to RECIST, V1.1.
Time Frame
From date of first documentation of cPR or better to the date of first documentation of progressive disease (PD) (up to 30 months)
Title
Time to Response (TTR) For all Tumor Lesions Assessed by Investigator as per RECIST v1.1
Description
TTR will be defined as the time from the date of first dose administration to the date of first documented cPR or better as determined by the investigator according to RECIST, V1.1.
Time Frame
From the date of first dose administration to the date of first documented cPR or better (Up to 30 months)
Title
Overall Response Rate Assessed by Investigator as per Modified Intratumoral Immunotherapy RECIST (modified itRECIST)
Description
ORR will be defined as the percentage of participants who achieve confirmed complete response (cCR) or confirmed partial response (cPR) as determined by the investigator according to Modified itRECIST.
Time Frame
Up to 30 months
Title
Overall Response Rate For Tumors Within the Radiation Field (ORRirradiated)
Description
ORRirradiated will be defined as the percentage of participants who achieve cCRirradiated or cPRirradiated in the tumor lesions lying within the radiation field as determined by the investigator according to modified itRECIST.
Time Frame
Up to 30 months
Title
Overall Response Rate For Tumors Outside the Radiation Field (ORRnonirradiated)
Description
ORRnonirradiated will be defined as the percentage of participants who achieve cCRnonirradiated or cPRnonirradiated in the tumor lesions lying outside of the radiation field as determined by the investigator according to modified itRECIST.
Time Frame
Up to 30 months
Title
Duration of Response (DOR) For Tumors Within the Radiation Field (DORirradiated)
Description
DORirradiated for tumor lesions lying within radiation field will be defined as the time from the date of first documentation of a cPRirradiated or better to the date of first documentation of irradiated PD in those lesions for irradiated responders (cPRirradiated or better). Irradiated responders without documentation of irradiated PD will be censored at the date of last response assessment that is irradiated SD or better. Evaluation will be determined by the investigator according to modified itRECIST.
Time Frame
From date of first documentation of cPRirradiated or better to the date of first documentation of irradiated PD (up to 30 months)
Title
Duration of Response (DOR) For Tumors Outside the Radiation Field (DORnonirradiated)
Description
DORnonirradiated for tumor lesions lying outside of the radiation field will be defined as time from the date of first documentation of a cPRnonirradiated or better to the date of first documentation of nonirradiated PD in those lesions for nonirradiated responders (cPRnonirradiated or better). Nonirradiated responders without documentation of nonirradiated PD will be censored at the date of last response assessment that is nonirradiated SD or better. Evaluation will be determined by the investigator according to modified itRECIST.
Time Frame
From date of first documentation of cPRnonirradiated or better to the date of first documentation of nonirradiated PD (up to 30 months)
Title
Time to Response (TTR) For Tumors Within the Radiation Field (TTRirradiated)
Description
TTRirradiated in the tumor lesions lying within the radiation field will be defined as the time from the date of first dose administration to the date of first documented cPRirradiated or better as determined by the investigator according to modified itRECIST.
Time Frame
From the date of first dose administration to the date of first documented cPRirradiated or better (up to 30 months)
Title
Time to Response (TTR) For Tumors Outside the Radiation Field (TTRnonirradiated)
Description
TTRnonirradiated in the tumor lesions lying outside of the radiation field will be defined as the time from the date of first dose administration to the date of first documented cPRnonirradiated or better during the study in response-evaluable population as determined by the investigator according to modified itRECIST.
Time Frame
From the date of first dose administration to the date of first documented cPRnonirradiated or better (up to 30 months)
Title
Number of Participants with Increase in T-Cell Infiltration in Tumor Evaluated by Immunohistochemistry
Description
Participants with the increase in T-cell infiltration levels between the pretreatment and on-treatment tumor biopsies will be reported.
Time Frame
Up to approximately 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. Participants must have at least 2 measurable lesions (i.e. ≥10 mm longest diameter for extranodal lesions, ≥15 mm short axis for lymph nodes), with at least one inside and at least one other outside of the radiation field. The tumor outside the radiation field must be accessible for biopsy, and the participant must consent to tumor biopsy at screening and during treatment. Participants must have pathologically confirmed (cytological diagnosis is adequate) advanced or metastatic NSCLC, TNBC, or SCCHN who have: Received or been offered all established standard of care (SOC) treatment options for which they are eligible; and Progressed on CPIs in a prior line of therapy. Adequate bone marrow, renal and hepatic functions. Left ventricular ejection fraction (LVEF) >50%, as measured by echocardiogram or multiple-gated acquisition (MUGA) scan within 4 weeks before receiving the first dose of study drug. Clinically significant toxic effects of previous therapy have recovered to Grade 1 (per NCI CTCAE, V5.0) or baseline, except for alopecia, Grade 2 peripheral neuropathy, and/or autoimmune endocrinopathies with stable endocrine replacement therapy. Exclusion Criteria: History of any serious cardiac or cerebrovascular conditions in the last 6 months, including uncontrolled congestive heart disease, unstable angina, myocardial infarction, hypertension greater than or equal to (≥) 160/100 millimeter of mercury (mmHg) in spite of optimal therapy, cardiac arrhythmias, pericardial effusion, cardiomyopathy, or symptomatic stroke. Chronic, stable atrial fibrillation on stable anticoagulation therapy, including low molecular weight heparin, will be allowed. History of brain metastasis unless: Clinically stable, (that is, treatment completed ≥4 weeks prior) following prior surgery, whole-brain radiation, or stereotactic radiosurgery, AND Off corticosteroids. Known history of uncontrolled autoimmune disorders, human immunodeficiency virus (HIV) infection, or other relevant congenital or acquired immunodeficiencies. Chronic, active hepatitis (example, participants with known hepatitis B surface antigen seropositive and/or detectable hepatitis C virus [HCV]-ribonucleic acid [RNA]). Treatment with any investigational products and systemic anticancer drugs (including vascular endothelial growth factor (VEGF) inhibitors), within 14 days or 5 half-lives, whichever is shorter, before Cycle 1 Day 1 (C1D1) of study drugs. Prior radiation to lesions chosen for biopsy or response assessment. Prior radiation to lesions other than those chosen for radiation therapy or biopsy in the current protocol within 4 weeks of C1D1 of study drug(s). Use of systemic corticosteroids or other immunosuppressive therapy, concurrently or within 7 days of start of radiation therapy, 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). Receipt of live attenuated vaccine (example, tuberculosis Bacillus Calmette-guerin [BCG] vaccine, oral polio vaccine, measles, rotavirus, yellow fiver) within 28 days of C1D1 of study drug(s). Recipients of allogeneic or autologous stem cell transplantation or organ transplantation. Ongoing Grade ≥2 infection or participants with Grade ≥2 fever of malignant origin. Fridericia's corrected QT interval (QTcF) >450 milliseconds (msec) (males) or >475 msec (females) on a 12-lead electrocardiogram (ECG) during the screening period. Grade ≥2 hypotension (that is, hypotension for which nonurgent intervention is required) at screening or during C1D1 pre-dose assessment. Oxygen saturation less than (<) 92% on room air at screening or during C1D1 predose assessment. Use of medications that are known clinical organic anion transporting polypeptide 1B1 (OATP1B1) and/or OATP1B3 inhibitors, concurrently or within 14 days of C1D1 of study drugs. Current smoker. Vaping within 90 days of C1D1 of study drugs. Current diagnosis of pneumonitis, interstitial lung disease, severe chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis, other restrictive lung diseases, acute pulmonary embolism, or Grade ≥2 pleural effusion or ascites not controlled by tap or requiring indwelling catheters. Treated with other stimulator of interferon genes (STING) agonists/antagonist and toll-like receptors agonists within the past 6 months.
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
Cedars Sinai Medical Center
City
West Hollywood
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
310-423-8255
Email
yuanyuan@cshs.org
First Name & Middle Initial & Last Name & Degree
Yuan Yuan
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
773-702-9235
Email
SChmura@radonc.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Steven Chmura
Facility Name
Laura And Isaac Perlmutter Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
212-731-5003
Email
benjamin.cooper@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Benjamin Cooper
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
503-215-5401
Email
david.page2@providence.org
First Name & Middle Initial & Last Name & Degree
David Page
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Completed
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
615-936-8422
Email
wade.t.iams@vumc.org
First Name & Middle Initial & Last Name & Degree
Wade Thomas Iams

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/6099884f1f1122001e30a78e
Description
To obtain more information on the study, click here/on this link.

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A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers

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