A Study of TAK-981 Given With Pembrolizumab in Participants With Select Advanced or Metastatic Solid Tumors

NCT04381650 | Completed Phase 1 Results DMC FDA Drug

• 3 other identifiers: TAK-981-15022020-004325-23jRCT2031210417
• Study Type: interventional
• Target: 161
• Locations: 9 countries
• Sites: 52

Brief Summary

TAK-981 is being tested in combination with pembrolizumab to treat participants who have select advanced or metastatic solid tumors. The study aims are to evaluate the safety, tolerability, and preliminary efficacy of TAK-981 in combination with pembrolizumab. Participants will be on this combination treatment for 21-day cycles. They will continue with this treatment for up to 24 months or until participants meet any discontinuation criteria.

Conditions

Advanced or Metastatic Solid Tumors

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (7)

• Phase 1: Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs)

  An adverse event (AE) is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy. AEs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 except cytokine release syndrome (CRS), which was graded according to American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading for CRS.

  Up to approximately 24 months

• Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)

  DLTs were evaluated according to NCI CTCAE Version 5.0 except CRS, which was graded according to ASTCT Consensus Grading for CRS.

  Up to Cycle 1 (each cycle was of 21 days)

• Phase 1: Number of Participants With Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs)

  AE means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product whether or not it is related to the medicinal product. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug. A severity grade was evaluated as per the NCI CTCAE Version 5.0, except for CRS, which was assessed by ASTCT Consensus Grading for CRS.

  Up to approximately 24 months

• Phase 1: Number of Participants With One or More Serious Adverse Events (SAEs)

  An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent.

  Up to approximately 24 months

• Phase 1: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuation

  An AE is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy.

  Up to approximately 24 months

• Phase 1: Number of Participants With Clinically Significant Laboratory Values

  Laboratory parameters included clinical chemistry, hematology, and urinalysis. Participants with at least 1 Grade 3 or 4 Lab Abnormalities were reported.

  Up to approximately 24 months

• Phase 2: Overall Response Rate (ORR) as Assessed by the Investigator According to RECIST, Version 1.1

  ORR is defined as the percentage of participants who achieve Complete Response (CR) and Partial Response (PR) (determined by the investigator) during the study according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

  Up to approximately 25 months

Secondary Outcomes (19)

• Phase 1: Cmax: Maximum Observed Plasma Concentration for TAK-981

  Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours)

• Phase 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-981

  Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours)

• Phase 1: AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-981

  Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours)

• Phase 1: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-981

  Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours)

• Phase 1: t1/2z: Terminal Disposition Phase Half-life for TAK-981

  Cycle 1 (each cycle is 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours)

Study Arms (11)

Dose Escalation: TAK-981 40 mg + Pembrolizumab

EXPERIMENTAL

Participants received TAK-981 40 mg, intravenous (IV) infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the recommended Phase 2 dose (RP2D) was determined (for a maximum of 24 months).

Drug: TAK-981; Drug: Pembrolizumab

Dose Escalation: TAK-981 60 mg + Pembrolizumab

EXPERIMENTAL

Participants received TAK-981 60 mg, intravenous (IV) infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).

Drug: TAK-981; Drug: Pembrolizumab

Dose Escalation: TAK-981 90 mg + Pembrolizumab

EXPERIMENTAL

Participants received TAK-981 90 mg, intravenous (IV) infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).

Drug: TAK-981; Drug: Pembrolizumab

Dose Escalation: TAK-981 120 mg + Pembrolizumab

EXPERIMENTAL

Participants received TAK-981 120 mg, intravenous (IV) infusion, on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle and pembrolizumab 200 mg, IV infusion, as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle until the RP2D was determined (for a maximum of 24 months).

Drug: TAK-981; Drug: Pembrolizumab

Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 90 mg

EXPERIMENTAL

Participants with non-squamous non-small cell lung cancer (NSCLC) received TAK-981 as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.

Drug: TAK-981; Drug: Pembrolizumab

Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 120 mg

EXPERIMENTAL

Participants with NSCLC received TAK-981 as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.

Drug: TAK-981; Drug: Pembrolizumab

Dose Expansion Phase: Cohort B: Cervical Cancer

EXPERIMENTAL

Participants with cervical cancer received TAK-981 as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.

Drug: TAK-981; Drug: Pembrolizumab

Dose Expansion Phase: Cohort C: MSS-CRC

EXPERIMENTAL

Participants with microsatellite stable colorectal cancer (MSS-CRC) received TAK-981 as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.

Drug: TAK-981; Drug: Pembrolizumab

Dose Expansion Phase: Cohort D: Cutaneous Melanoma

EXPERIMENTAL

Participants with cutaneous melanoma received TAK-981 as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.

Drug: TAK-981; Drug: Pembrolizumab

Dose Expansion Phase: Cohort E: Squamous NSCLC

EXPERIMENTAL

Participants with squamous NSCLC received TAK-981 as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.

Drug: TAK-981; Drug: Pembrolizumab

Dose Expansion Phase: Cohort F: CPI Refractory Squamous or Nonsquamous NSCLC

EXPERIMENTAL

Participants with checkpoint inhibitors (CPI) refractory squamous or non-squamous NSCLC received TAK-981 as IV infusion on Days 1, 4, 8 and 11 or Days 1 and 8 in each 21-day Treatment Cycle up to disease progression or 24-months and pembrolizumab 200 mg IV infusion as a fixed dose every 3 weeks on Day 1 of 21-day Treatment Cycle for a maximum of 24 months.

Drug: TAK-981; Drug: Pembrolizumab

Interventions

TAK-981 DRUG

TAK-981 IV infusion.

Dose Escalation: TAK-981 120 mg + Pembrolizumab; Dose Escalation: TAK-981 40 mg + Pembrolizumab; Dose Escalation: TAK-981 60 mg + Pembrolizumab; Dose Escalation: TAK-981 90 mg + Pembrolizumab; Dose Expansion Phase: Cohort B: Cervical Cancer; Dose Expansion Phase: Cohort C: MSS-CRC; Dose Expansion Phase: Cohort D: Cutaneous Melanoma; Dose Expansion Phase: Cohort E: Squamous NSCLC; Dose Expansion Phase: Cohort F: CPI Refractory Squamous or Nonsquamous NSCLC; Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 120 mg; Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 90 mg

Pembrolizumab DRUG

Pembrolizumab IV infusion.

Dose Escalation: TAK-981 120 mg + Pembrolizumab; Dose Escalation: TAK-981 40 mg + Pembrolizumab; Dose Escalation: TAK-981 60 mg + Pembrolizumab; Dose Escalation: TAK-981 90 mg + Pembrolizumab; Dose Expansion Phase: Cohort B: Cervical Cancer; Dose Expansion Phase: Cohort C: MSS-CRC; Dose Expansion Phase: Cohort D: Cutaneous Melanoma; Dose Expansion Phase: Cohort E: Squamous NSCLC; Dose Expansion Phase: Cohort F: CPI Refractory Squamous or Nonsquamous NSCLC; Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 120 mg; Dose Expansion: Cohort A: Non-squamous NSCLC TAK-981 90 mg

Eligibility Criteria

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

You may qualify if:

• Has a histologically or cytologically documented, advanced (metastatic and/or unresectable) cancer as listed below that is incurable: Note: Prior neoadjuvant or adjuvant therapy included in initial treatment may not be considered first- or later-line standard of care treatment unless such treatments were completed less than 12 months prior to the current tumor recurrence.
• A. Non-squamous NSCLC for which prior standard first-line treatment containing an anti-programmed cell death protein 1/programmed cell death protein 1 ligand (PD-1/PD-L1) checkpoint inhibitor (CPI) alone or in combination has failed and that has progressed on no more than 1 prior systemic therapy. In Phase 2, participants with nonsquamous NSCLC must have not received more than 1 prior systemic therapy and must not have presented with disease progression during the first 6 months of treatment with first-line CPI/anti-PD-(1/L1)-containing therapy.
• Note: In Phase 1, participants with nonsquamous NSCLC and known driver mutations/genomic aberrations (e.g., epidermal growth factor receptor (EGFR), B-Raf proto-oncogene mutation V600E \[BRAF V600E\], and ROS proto-oncogene 1 \[ROS1\] sensitizing mutations, neurotrophic receptor tyrosine kinase \[NRTK\] gene fusions, and anaplastic lymphoma kinase \[ALK\] rearrangements) must have also shown progressive disease after treatment with a commercially available targeted therapy. In Phase 2, participants with driver mutations are not eligible.
• B. CPI-naive cervical cancer (squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix) participants for whom prior standard first-line treatment has failed and who have received no more than 1 prior systemic line of therapy for recurrent or Stage IVB cervical cancer. Note: The following cervical tumors are not eligible: minimal deviation/adenoma malignum, gastric-type adenocarcinoma, clear-cell carcinoma, and mesonephric carcinoma. Histologic confirmation of the original primary tumor is required via pathology report. Note: First-line treatment must have consisted of platinum-containing doublet. Chemotherapy administered concurrently with primary radiation (e.g., weekly cisplatin) is not counted as a systemic chemotherapy regimen.
• C. CPI-naïve microsatellite stable-colorectal cancer (MSS-CRC) participants for whom prior standard first-line treatment has failed and who have progressed on no more than 3 chemotherapy regimens.
• Note: Participants must have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing regimens if indicated.
• D. Unresectable Stage III or Stage IV cutaneous melanoma that has not received prior therapy in the metastatic setting.
• Note: Participants with acral melanoma are not eligible. Participants who have presented with disease relapse after ≥6 months of the last dose of CPI or BRAF-mitogen-activated protein kinase kinase (MEK) inhibitor in the adjuvant setting are eligible.
• E. Squamous NSCLC for which prior standard first-line treatment containing an anti-PD-(1/L1) checkpoint inhibitor alone or in combination has failed. Participant must have not received more than 1 prior systemic therapy and must not have presented with disease progression during the first 6 months of treatment with first-line CPI/anti-PD-(1/L1)-containing therapy.
• F. Squamous or nonsquamous NSCLC for which prior standard first-line treatment containing an anti-PD-(1/L1) checkpoint inhibitor alone or in combination has failed within 6 months from the initiation of the CPI. Participants must not have received more than 1 prior systemic therapy in the metastatic setting.
• Note: Participants with driver mutations are not eligible.
• Has at least 1 radiologically measurable lesion based on RECIST, Version 1.1. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
• Has a performance status of 0 or 1 on the Eastern Cooperative Group Oncology (ECOG) Performance Scale.
• Has left ventricular ejection fraction (LVEF) ≥40%; as measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan.
• Has recovered to Grade 1 or baseline from all toxicity associated with previous therapy or have the toxicity established as sequela. Note: Has a neuropathy ≤Grade 2, any grade alopecia, or autoimmune endocrinopathies with stable replacement therapy are permitted.

You may not qualify if:

• History of uncontrolled brain metastasis (evidence of progression by imaging over a period of 4 weeks and/or neurologic symptoms that have not returned to baseline). Participant with treated brain metastases are allowed provided they are radiologically stable, without evidence of progression for at least 4 weeks by repeat imaging, clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment. Note: For asymptomatic participants, screening brain imaging is not required.
• Second malignancy within the previous 3 years, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, cervical carcinoma in situ, resected colorectal adenomatous polyps, breast cancer in situ, or other malignancy for which the participant is not on active anticancer therapy.
• Major surgery ≤14 days from the first dose of study drug and not recovered fully from any complications from surgery.
• History of immune-related AEs related to treatment with immune CPIs that required treatment discontinuation.
• Receiving or requires the continued use of medications that are known to be strong or moderate inhibitors and inducers of cytochrome P-450 (CYP) 3A4/5 and strong P-glycoprotein (Pgp) inhibitors.
• Baseline prolongation of the QT interval corrected using Fridericia's formula (QTcF) (e.g., repeated demonstration of QTcF interval \>480 milliseconds (ms), history of congenital long QT syndrome, or torsades de pointes).
• Has a history of autoimmune disease requiring systemic immunosuppressive therapy with daily doses of prednisone \>10 mg/day or equivalent doses, or any other form of immunosuppressive therapy. Hormone replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for thyroid, adrenal or pituitary insufficiency) for endocrinopathies are not considered prohibited forms of systemic treatment of an autoimmune disease.
• Has a history of noninfectious pneumonitis that required steroids or a history of interstitial lung disease.
• Has an evidence of active, non-infectious pneumonitis.
• Has a history of allogeneic tissue or solid organ transplant.
• Has an active infection requiring systemic therapy.
• Has a known history of human immunodeficiency virus (HIV) infection or any other relevant congenital or acquired immunodeficiency.
• Has a known hepatitis B virus surface antigen seropositive or detectable hepatitis C infection viral load. Note: Participants who have positive hepatitis B core antibody or hepatitis B surface antigen antibody can be enrolled but must have an undetectable hepatitis B viral load.
• History of any of the following ≤6 months before first dose: congestive heart failure New York Heart Association Grade III or IV, unstable angina, myocardial infarction, unstable symptomatic ischemic heart disease, uncontrolled hypertension despite appropriate medical therapy, ongoing symptomatic cardiac arrhythmias \>Grade 2, pulmonary embolism or symptomatic cerebrovascular events, or any other serious cardiac condition (e.g., pericardial effusion or restrictive cardiomyopathy). Chronic atrial fibrillation on stable anticoagulant therapy is allowed.
• Psychiatric illness/social circumstances that would limit compliance with study requirements and substantially increase the risk of AEs or has compromised ability to provide written informed consent.

Sponsors & Collaborators

• Takeda: lead
• Takeda Development Center Americas, Inc.: collaborator

Study Sites (52)

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

Stanford Cancer Institute (SCI)

Stanford, California, 94305, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520, United States

Location

Georgia Cancer Center at Augusta University

Augusta, Georgia, 30912, United States

Location

The Center for Cancer and Blood Disorders - PPDS

Bethesda, Maryland, 20817, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Montefiore Einstein Cancer Center - BRANY - PPDS

The Bronx, New York, 10461, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

University of Oklahoma Peggy and Charles Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Providence Cancer Institute, Franz Clinic

Portland, Oregon, 97213, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

START South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Virginia Cancer Specialists (Fairfax) - USOR

Fairfax, Virginia, 22031, United States

Location

Instituto de Oncologia Do Parana

Curitiba, Paraná, 80530-010, Brazil

Location

ONCOSITE Centro de Pesquisa Clinica Em Oncologia

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Fundacao Pio XII Hospital de Cancer de Barretos

Barretos, São Paulo, 14784-370, Brazil

Location

Hospital de Base Da Faculdade de Medicina de Sao Jose Do Rio Preto

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Cetus Hospital Dia Oncologia

Belo Horizonte, 30110-140, Brazil

Location

INCA Instituto Nacional de Cancer

Rio de Janeiro, 20230-230, Brazil

Location

Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira

Rio de Janeiro, 20941-150, Brazil

Location

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine - PPDS

Hangzhou, Zhejiang, 310003, China

Location

Klinicki bolnicki centar Zagreb

Zagreb, City of Zagreb, 10000, Croatia

Location

Clinical Hospital Centre Osijek

Osijek, 31000, Croatia

Location

General Hospital Pula

Pula, 52100, Croatia

Location

University Hospital Centre Split

Split, 21000, Croatia

Location

National Cancer Center East

Kashiwa-Shi, Chiba, 277-0882, Japan

Location

National Cancer Center Hospital

Chuo-Ku, Tokyo, 104-0045, Japan

Location

The Cancer Institute Hospital of Japanese Foundation For Cancer Research

Chuo-Ku, Tokyo, 104-0045, Japan

Location

Pauls Stradins Clinical University Hospital

Riga, LV-1002, Latvia

Location

Riga East Clinical University Hospital Latvian Oncology Center

Riga, LV-1079, Latvia

Location

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, Kaunas County, LT-50161, Lithuania

Location

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, Kaunas County, LT-50161, Lithuania

Location

National Cancer Institute

Vilnius, Vilnius County, LT-08660, Lithuania

Location

Uniwersyteckie Centrum Kliniczne-Ul. Smoluchowskiego 17

Gdansk, Pomeranian Voivodeship, 80-214, Poland

Location

Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

Bydgoszcz, 85-796, Poland

Location

Instytut Medyczny Santa Familia Sp. z o. o.

Lodz, 90-302, Poland

Location

Specjalistyczna Praktyka Lekarska Slawomir Mandziuk

Lublin, 20-362, Poland

Location

Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie

Olsztyn, 10-357, Poland

Location

Med-Polonia Sp. z o.o.

Poznan, 60-569, Poland

Location

Centrum Terapii Wspolczesnej

Lodz, Łódź Voivodeship, 90-242, Poland

Location

Kantonsspital Muensterlingen

Münsterlingen, Thurgau (de), 8596, Switzerland

Location

Kantonsspital Winterthur

Winterthur, Zurich (de), 8400, Switzerland

Location

Universitaetsspital Bern - Inselspital

Bern, 3010, Switzerland

Location

Related Publications (2)

• Liu H, Seo S, Joung H. TAK-981 enhances antitumor activity in ELT3 uterine leiomyoma cells through the modulation of apoptosis, cell cycle arrest, and autophagy. Biochem Biophys Res Commun. 2025 Jul 12;770:152000. doi: 10.1016/j.bbrc.2025.152000. Epub 2025 May 12.

  PMID: 40373381 DERIVED

• Nakamura A, Grossman S, Song K, Xega K, Zhang Y, Cvet D, Berger A, Shapiro G, Huszar D. The SUMOylation inhibitor subasumstat potentiates rituximab activity by IFN1-dependent macrophage and NK cell stimulation. Blood. 2022 May 5;139(18):2770-2781. doi: 10.1182/blood.2021014267.

  PMID: 35226739 DERIVED

Related Links

• To obtain more information about this study, click this link.

MeSH Terms

Interventions

TAK-981; pembrolizumab

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Model Details: This study has 2 Phases. Phase 1 is dose escalation phase with sequential drug assignment. Phase 2 is parallel assignment.

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 11, 2020
• Study Start: August 17, 2020
• Primary Completion: October 29, 2024
• Study Completion: October 29, 2024
• Last Updated: December 10, 2025
• Results First Posted: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

PL (7); JP (3); US (18); LI (3); CH (3); CR (4); BR (9); LA (2); CN (3)