A Study of Modakafusp Alfa (TAK-573) Given by Itself and Together With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors

Stopped early · Phase 1/Phase 2

Conditions studied: Neoplasms, Melanoma

In brief

This study has 2 phases. The main aims of Phase 1b are: * to check for side effects from modakafusp alfa in adults with locally advanced or metastatic solid tumors. * to learn how much modakafusp alfa adults can receive without getting any major side effects from it. The main aims of Phase 2 are: * to check for side effects from modakafusp alfa when given together with pembrolizumab in adults with metastatic cutaneous melanoma which cannot be completely removed by surgery. * to learn how these medicines improve their symptoms. Participants will receive modakafusp alfa for up to 1 year (Phase 1b) or modakafusp alfa given together with pembrolizumab for up to 2 years (Phase 2). Those whose symptoms improve might continue treatment for longer. In both phases of the study, participants will revisit the study clinic within 30 days after their last dose or before they start other cancer treatment, whichever happens first.

Key facts

Study ID

NCT04157517

Run by

Teva Branded Pharmaceutical Products R&D LLC

People needed

45

Starts

2019-12-12

Expected to finish

2023-12-20

Last updated by the study team

2026-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• For both the dose escalation and expansion cohort phases of the study, eligible participants must have histologically confirmed advanced (locoregionally recurrent, not amenable to curative therapy) or metastatic solid tumors.
• Measurable disease per RECIST v1.1. At least 1 target lesion amenable for biopsy is required for enrollment in phase 1b. A minimum of 1 target lesion for response assessment is required for enrollment in phase 2. A separate lesion amenable for biopsy is required for enrollment in phase 2 for cohorts I and II post futility analysis and for all participants (safety lead-in and expansion) with subgroup III melanoma.
• Phase 1b Dose Escalation: Participants with histologically confirmed advanced locally (locoregionally recurrent, not amenable to curative therapy) or metastatic solid tumors.
• Phase 2 Dose Expansion:
• The combination cohorts, including participants in the safety-lead phase, will enroll participants with unresectable/metastatic melanoma in the following subgroups:
• I. Unresectable/metastatic histologically confirmed cutaneous melanoma with primary resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting.
• II. Unresectable/metastatic histologically confirmed cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting.
• III. Unresectable/metastatic histologically confirmed cutaneous melanoma naive to prior anti-PD1 containing treatments in the metastatic setting.
• Participants with BRAF V600E mutant melanoma may have received prior BRAF inhibitor therapy.
• For the expansion cohorts I and II, there is no limitation of total number of prior line(s) of therapy, but the number of prior line(s) containing anti-PD1 must be ≤2 in the metastatic setting.
• For the expansion cohort III, participants who received an anti-PD-1 treatment in the adjuvant setting must have completed that treatment at least 6 months prior to enrollment and must not have progressed on the anti-PD1 adjuvant treatment.
• Primary resistance is defined as a best response of PD or SD less than (<) 6 months to an anti-PD1 alone or in combination with other agents (that is, CTLA4) in the initial anti-PD1 containing treatment.
• Acquired resistance is defined as a progression following a best response of CR, PR or SD>6 months to a prior anti-PD1 alone or in combination with other agents (that is, CTLA4).

You may not qualify if…

• Persistent toxicity from previous treatments that has not resolved to less than or equal to (<=) CTCAE version 5.0 Grade 1 prior to administration of modakafusp alfa, except for alopecia, Grade 2 neuropathy, and Grade 2 asthenia/fatigue, or autoimmune endocrinopathies with stable replacement therapy.
• History of any of the following <=6 months before first dose modakafusp alfa: New York Heart Association (NYHA) Grade III or IV congestive heart failure, unstable angina, myocardial infarction, unstable symptomatic ischemic heart disease, any ongoing symptomatic cardiac arrhythmias of Grade >2, pulmonary embolism, or symptomatic cerebrovascular events, or any other serious cardiac condition (example, symptomatic pericardial effusion or restrictive cardiomyopathy). Chronic, stable atrial fibrillation on stable anticoagulant therapy, including low molecular-weight heparin, is allowed.
• Baseline QT interval with Fridericia's correction (QTcF) greater than (>) 480 millisecond (msec) (Grade >=2), history of congenital long QT syndrome, or torsades de pointes.
• Patients with acral lentiginous melanoma are excluded in phase 2 except for the safety lead-in phase.
• Ongoing or active infection.
• Known history of human immunodeficiency virus (HIV) infection or any other relevant congenital or acquired immunodeficiency. Testing during screening period is required only if indicated by specific local regulations or investigator's criteria.
• Known hepatitis B (HBV) surface antigen seropositive or detectable hepatitis C infection viral load. Note: Participants with a positive HBV core antibody can be enrolled but must have an undetectable hepatitis B viral load.
• Autoimmune disease requiring systemic immunosuppressive therapy. Participants with immune mediated endocrine deficiency from previous therapy with stable hormone replacement are exceptions.

Where it is running

• City of Hope Comprehensive Cancer Center - Duarte — Duarte, California, United States
• University of California San Diego Moores Cancer Center — La Jolla, California, United States
• The Angeles Clinic and Research Institute - West Los Angeles Office — Los Angeles, California, United States
• University of Colorado Health Memorial Hospital Central — Colorado Springs, Colorado, United States
• Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Orlando Health Cancer Institute — Orlando, Florida, United States
• Norris Cotton Cancer Center Lebanon — Lebanon, New Hampshire, United States
• Morristown Medical Center — Morristown, New Jersey, United States
• Cleveland Clinic Main Campus — Cleveland, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Avera Cancer Institute — Sioux Falls, South Dakota, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Texas Oncology - Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States
• Intermountain Medical Center — Murray, Utah, United States
• West Virginia University Health Sciences Campus — Morgantown, West Virginia, United States
• The Queen Elizabeth Hospital — Woodville South, South Australia, Australia
• Ballarat Regional Integrated Cancer Center — Ballarat, Victoria, Australia

Full record on ClinicalTrials.gov

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