Melanoma Clinical Trial

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

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.

View Full Description

Full Description

The drug being tested in this study is called TAK-981. TAK-981 is being tested to treat people who have select advanced or metastatic solid tumors. The study will include a dose escalation phase and a dose expansion phase.

The study will enroll approximately 265 patients, approximately 32 participants in the dose escalation phase 1 and approximately 85 to 233 participants in the 9 cohorts of dose expansion phase 2. Participants will receive escalating doses of TAK-981 and fixed dose of pembrolizumab until recommended Phase 2 dose (RP2D) is determined:

• Dose Escalation: TAK-981 + Pembrolizumab (fixed dose)

Once Phase 2 doses are identified, participants of select advanced or metastatic solid tumors will receive TAK-981 in below defined cohorts in the expansion phase 2:

Dose Expansion Phase: Cohort A: Non-squamous Non-small Cell Lung Cancer (NSCLC)
Dose Expansion Phase: Cohort B: Cervical Cancer
Dose Expansion Phase: Cohort C: Microsatellite Stable Colorectal Cancer (MSS-CRC)
Dose Expansion Phase: Cohort D: Cutaneous Melanoma
Dose Expansion Phase: Cohort E: Squamous NSCLC
Dose Expansion Phase: Cohort F: Small Cell Lung Cancer
Dose Expansion Phase: Cohort G: Head and Neck Squamous Cell Carcinoma (HNSCC)
Dose Expansion Phase: Cohort H: Microsatellite Instability, High Levels/ Mismatch-repair-deficient Colorectal Cancer (MSI-H/dMMR CRC)

This multi-center trial will be conducted worldwide. The overall time to participate in this study is 48 months. Participants will make multiple visits to the clinic, and progression-free survival follow-up for maximum up to 12 months after last dose of study drug.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 to no more than 1 prior systemic therapy. In Phase 2, participants with non-squamous 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 non-squamous 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 with a CPI in the metastatic setting.

Note: 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. SCLC that has progressed during or after first-line platinum-based chemotherapy regimen or equivalent if platinum-based therapy is contraindicated.

G. HNSCC (oral cavity, pharynx, larynx) not amenable to local therapy with curative intent that has progressed:

Within 6 months of the last dose of platinum therapy in the adjuvant (i.e., with radiation after surgery) or primary (i.e., with radiation) settings, or
On or after 1 prior systemic immune CPI/anti-PD-(1/L1)-containing therapy in the metastatic setting. HNSCC 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 or anti-PD-(1/L1)-containing therapy.

H. Treatment-naïve MSI-H/dMMR CRC.

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.
Demonstrate adequate organ function as described below:

A. Platelet count ≥75.0 × 10^9/L. B. Absolute neutrophil count (ANC) ≥1.0 × 10^9/L. C. Hemoglobin ≥85 g/L (red blood cell [RBC] transfusion allowed ≥14 days before assessment).

D. Calculated creatinine clearance ≥30 mL/min using the Cockcroft-Gault formula.

E. Aspartate aminotransferase (AST, GOT) and alanine aminotransferase (ALT, GPT) ≤3.0 times the upper limit of normal (ULN), <5.0 times the ULN if liver enzyme elevations are due to liver metastases; bilirubin ≤1.5 times the ULN. Participants with Gilbert's syndrome may have a bilirubin level >1.5 times the ULN, per discussion between the investigator and the medical monitor.

Exclusion Criteria:

Received extended field radiotherapy ≤4 weeks before the start of treatment (≤7 days for limited field radiation for palliation outside the chest or brain).
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 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 therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered an excluded form 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.

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

265

Study ID:

NCT04381650

Recruitment Status:

Recruiting

Sponsor:

Takeda

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There are 58 Locations for this study

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HonorHealth
Scottsdale Arizona, 85258, United States More Info
Site Contact
Contact
480-323-1350
[email protected]
Sunil Sharma
Principal Investigator
University of California Irvine Medical Center
Orange California, 92868, United States More Info
Site Contact
Contact
714-456-7356
[email protected]
Krishnansu Tewari
Principal Investigator
Stanford Cancer Institute (SCI)
Stanford California, 94305, United States More Info
Site Contact
Contact
650-507-5624
[email protected]
Christopher Chen
Principal Investigator
Yale Cancer Center
New Haven Connecticut, 06520, United States More Info
Site Contact
Contact
203-785-5944
[email protected]
Patricia LoRusso
Principal Investigator
Georgia Cancer Center at Augusta University
Augusta Georgia, 30912, United States More Info
Site Contact
Contact
706-721-3977
[email protected]
Sharad Ghamande
Principal Investigator
The Center for Cancer and Blood Disorders - PPDS
Bethesda Maryland, 20817, United States More Info
Site Contact
Contact
301-571-0019
[email protected]
Victor Priego
Principal Investigator
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Site Contact
Contact
617-724-4000
[email protected]
Andreas Varkaris
Principal Investigator
Morristown Medical Center
Morristown New Jersey, 07960, United States More Info
Site Contact
Contact
973-971-7111
[email protected]
Eric Whitman
Principal Investigator
Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States More Info
Site Contact
Contact
646-685-9242
[email protected]
Sanjay Goel
Principal Investigator
Montefiore Einstein Cancer Center - BRANY - PPDS
Bronx New York, 10461, United States More Info
Site Contact
Contact
857-236-8272
[email protected]
Eric Feldman
Principal Investigator
University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27514, United States More Info
Site Contact
Contact
919-843-7713
[email protected]
Stergios Moschos
Principal Investigator
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States More Info
Site Contact
Contact
614-293-6786
[email protected]
Kai He
Principal Investigator
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States More Info
Site Contact
Contact
405-271-8001
[email protected]
Susanna Ulahannan
Principal Investigator
Providence Cancer Institute, Franz Clinic
Portland Oregon, 97213, United States More Info
Site Contact
Contact
503-215-5696
[email protected]
Rachel Sanborn
Principal Investigator
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States More Info
Site Contact
Contact
215-214-1676
[email protected]
Anthony Olszanski
Principal Investigator
UPMC Hillman Cancer Center
Pittsburgh Pennsylvania, 15213, United States More Info
Site Contact
Contact
412-623-2294
[email protected]
Yana Najjar
Principal Investigator
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States More Info
Site Contact
Contact
214-645-4673
[email protected]
Jade Homsi
Principal Investigator
START South Texas Accelerated Research Therapeutics
San Antonio Texas, 78229, United States More Info
Site Contact
Contact
210-593-5250
[email protected]
Drew Rasco
Principal Investigator
University of Virginia Health System
Charlottesville Virginia, 22908, United States More Info
Site Contact
Contact
434-297-5504
[email protected]
Matthew Reilley
Principal Investigator
Virginia Cancer Specialists (Fairfax) - USOR
Fairfax Virginia, 22031, United States More Info
Site Contact
Contact
703-208-3108
[email protected]
Alexander Spira
Principal Investigator
Instituto de Oncologia Do Parana
Curitiba Parana, 80530, Brazil More Info
Site Contact
Contact
+554132079788
[email protected]
Johnny Camargo
Principal Investigator
ONCOSITE Centro de Pesquisa Clinica Em Oncologia
Ijui Rio Grande Do Sul, 98700, Brazil More Info
Site Contact
Contact
+555533319393
[email protected]
Fabio Franke
Principal Investigator
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre Rio Grande Do Sul, 90035, Brazil More Info
Site Contact
Contact
+555133598619
[email protected]
Sergio de Azevedo
Principal Investigator
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre Rio Grande Do Sul, 90610, Brazil More Info
Site Contact
Contact
+555133203039
[email protected]
Carlos Barrios
Principal Investigator
Centro De Pesquisa E Ensino Em Oncologia De Santa Catarina - Cepen
Florianopolis Santa Catarina, 88034, Brazil More Info
Site Contact
Contact
+554833311553
[email protected]
Rita da Silva Baptista
Principal Investigator
Fundacao Pio XII Hospital de Cancer de Barretos
Barretos Sao Paulo, 14784, Brazil More Info
Site Contact
Contact
+558888888888
[email protected]
Arinilda Campos Bragagnoli
Principal Investigator
Hospital de Base Da Faculdade de Medicina de Sao Jose Do Rio Preto
Sao Jose Do Rio Preto Sao Paulo, 15090, Brazil More Info
Site Contact
Contact
+551732015054
[email protected]
Joao Daniel Cardoso Guedes
Principal Investigator
Cetus Hospital Dia Oncologia
Belo Horizonte , 30110, Brazil More Info
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Contact
+553135191686
[email protected]
Bruno Aragao
Principal Investigator
Instituto Mederi de Pesquisa e Saude
Curitiba , 99001, Brazil More Info
Site Contact
Contact
+555435811831
[email protected]
Felipe Thome dos Santos
Principal Investigator
INCA Instituto Nacional de Cancer
Rio De Janeiro , 20230, Brazil More Info
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Contact
+21969024255
[email protected]
Flora de Moraes Lino da Silva
Principal Investigator
Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
Rio de Janeiro , 20941, Brazil More Info
Site Contact
Contact
+5511994869758
[email protected]
Camila Venchiarutti Moniz
Principal Investigator
Sun Yat-Sen University Cancer Center
Guangzhou Guangdong, 51006, China More Info
Site Contact
Contact
+862087343228
[email protected]
Ruihua Xu
Principal Investigator
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan Hubei, , China More Info
Site Contact
Contact
+8613307187507
[email protected]
Guiling Li
Principal Investigator
The First Affiliated Hospital, Zhejiang University School of Medicine - PPDS
Hangzhou Zhejiang, 31000, China More Info
Site Contact
Contact
+8615257126683
[email protected]
Haiping Jiang
Principal Investigator
Klinicki bolnicki centar Zagreb
Zagreb Grad Zagreb, 10000, Croatia More Info
Site Contact
Contact
+38512385317
[email protected]
Marko Jakopovic
Principal Investigator
Clinical Hospital Centre Osijek
Osijek , 31000, Croatia More Info
Site Contact
Contact
+38531511490
[email protected]
Ivana Canjko
Principal Investigator
General Hospital Pula
Pula , 52100, Croatia More Info
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Contact
+38598335797
[email protected]
Dragan Trivanovic
Principal Investigator
University Hospital Centre Split
Split , 21000, Croatia More Info
Site Contact
Contact
+38521556539
[email protected]
Vide Popovic
Principal Investigator
National Cancer Center East
Kashiwa-Shi Tiba, 277-0, Japan More Info
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Contact
+81471331111
[email protected]
Kenichi Harano
Principal Investigator
National Cancer Center Hospital
Chuo-Ku Tokyo, 104-0, Japan More Info
Site Contact
Contact
+81335475201
[email protected]
Noboru Yamamoto
Principal Investigator
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Chuo-Ku Tokyo, 104-0, Japan More Info
Site Contact
Contact
+81335422511
[email protected]
Shigehisa Kitano
Principal Investigator
Pauls Stradins Clinical University Hospital
Riga , LV-10, Latvia More Info
Site Contact
Contact
+37129453125
[email protected]
Aija Gerina-Berzina
Principal Investigator
Riga East Clinical University Hospital Latvian Oncology Center
Riga , LV-10, Latvia More Info
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Contact
+37129455458
[email protected]
Alinta Hegmane
Principal Investigator
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas Kauno Apskritis, LT-50, Lithuania More Info
Site Contact
Contact
+37061533001
[email protected]
Laura Kairevice
Principal Investigator
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas Kauno Apskritis, LT-50, Lithuania More Info
Site Contact
Contact
+37037327125
[email protected]
Marius Zemaitis
Principal Investigator
National Cancer Institute
Vilnius Vilniaus Apskritis, LT-08, Lithuania More Info
Site Contact
Contact
+37052786700
[email protected]
Edita Baltruskeviciene
Principal Investigator
Centrum Terapii Wspolczesnej
Lodz Lodzkie, 90-24, Poland More Info
Site Contact
Contact
+48422300609
[email protected]
Malgorzata Ulanska
Principal Investigator
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warszawa Mazowieckie, 02-78, Poland More Info
Site Contact
Contact
+48225463381
[email protected]
Iwona Lugowska
Principal Investigator
Uniwersyteckie Centrum Kliniczne-Ul. Smoluchowskiego 17
Gdansk Pomorskie, 80-21, Poland More Info
Site Contact
Contact
+48583492979
[email protected]
Rafal Dziadziuszko
Principal Investigator
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
Bydgoszcz , 85-79, Poland More Info
Site Contact
Contact
+48501446778
[email protected]
Bogdan Zurawski
Principal Investigator
Instytut Medyczny Santa Familia Sp. z o. o.
Lodz , 90-30, Poland More Info
Site Contact
Contact
+48426895477
[email protected]
Ewa Kalinka
Principal Investigator
Specjalistyczna Praktyka Lekarska Slawomir Mandziuk
Lublin , 20-36, Poland More Info
Site Contact
Contact
+48814402474
[email protected]
Slawomir Mandziuk
Principal Investigator
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
Olsztyn , 10-35, Poland More Info
Site Contact
Contact
+48895322978
[email protected]
Jaroslaw Kolb-Sielecki
Principal Investigator
Med-Polonia Sp. z o.o.
Poznan , 60-56, Poland More Info
Site Contact
Contact
+48616561700
[email protected]
Rodryg Ramlau
Principal Investigator
Institute for Oncology and Radiology of Serbia - PPDS
Belgrade , 11000, Serbia More Info
Site Contact
Contact
+381642028674
[email protected]
Marijana Milovic Kovacevic
Principal Investigator
Clinical Hospital Center Bezanijska Kosa
Belgrade , 11070, Serbia More Info
Site Contact
Contact
+381113010700
[email protected]
Zoran Andric
Principal Investigator
Euromedik
Belgrade , 19051, Serbia More Info
Site Contact
Contact
+381644225304
[email protected]
Sanja Kostic
Principal Investigator
Health Center Kladovo
Kladovo , 19320, Serbia More Info
Site Contact
Contact
+381638462342
[email protected]
Milorad Micovic
Principal Investigator
University Clinical Center Kragujevac
Kragujevac , 55230, Serbia More Info
Site Contact
Contact
+381643630202
[email protected]
Jasmina Nedovic
Principal Investigator
Institute of Pulmonary Diseases of Vojvodina
Sremska Kamenica , 41090, Serbia More Info
Site Contact
Contact
+381214805224
[email protected]
Bojan Zaric
Principal Investigator
Kantonsspital Muensterlingen
Munsterlingen Thurgau (de), 8596, Switzerland More Info
Site Contact
Contact
+41716862202
[email protected]
Ioannis Metaxas
Principal Investigator
Kantonsspital Winterthur
Winterthur Zurich (de), 8400, Switzerland More Info
Site Contact
Contact
+418888888888
[email protected]
Laetitia Mauti
Principal Investigator
Universitaetsspital Bern - Inselspital
Bern , 3010, Switzerland More Info
Site Contact
Contact
+41316326858
[email protected]
Julian Wampfler
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

265

Study ID:

NCT04381650

Recruitment Status:

Recruiting

Sponsor:


Takeda

How clear is this clinincal trial information?

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