A Study of Modakafusp Alfa (TAK-573) Given by Itself and Together With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors
Public ClinicalTrials.gov record NCT04157517. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label, Dose-Escalation Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of Modakafusp Alfa (TAK-573) as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced or Metastatic Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04157517
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 45 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 12, 2019 (Actual)
- Primary completion
- Dec 20, 2023 (Actual)
- Completion
- Dec 20, 2023 (Actual)
- Last update posted
- Jan 29, 2026
2019 – 2023
United States locations
- U.S. sites
- 15
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center - Duarte | Duarte | California | 91010 | — |
| University of California San Diego Moores Cancer Center | La Jolla | California | 92093 | — |
| The Angeles Clinic and Research Institute - West Los Angeles Office | Los Angeles | California | 90025 | — |
| University of Colorado Health Memorial Hospital Central | Colorado Springs | Colorado | 80909 | — |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| Orlando Health Cancer Institute | Orlando | Florida | 32806 | — |
| Norris Cotton Cancer Center Lebanon | Lebanon | New Hampshire | 03756 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| Cleveland Clinic Main Campus | Cleveland | Ohio | 44195 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | — |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | — |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | — |
| Intermountain Medical Center | Murray | Utah | 84107 | — |
| West Virginia University Health Sciences Campus | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04157517, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 29, 2026 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04157517 live on ClinicalTrials.gov.