Trial · NCT04157517
A Study of Modakafusp Alfa (TAK-573) Given by Itself and Together With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors
NCT04157517, Phase 1, Phase 2, Terminated, Teva Branded Pharmaceutical Products R&D LLC; results first posted 2024-12-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Modakafusp Alfa (TAK-573) Given by Itself and Together With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors. Trials, record NCT04157517. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04157517
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Modakafusp Alfa (TAK-573) Given by Itself and Together With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors
- NCT number
- NCT04157517
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLC
- Conditions
- Neoplasms, Melanoma
- Interventions
- Modakafusp Alfa, Pembrolizumab
- First posted
- 2019-11-08
- Last updated
- 2026-01-29
- Results first posted
- 2024-12-27
- Limitations and caveats
- Study was terminated early due to futility.
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1b and Phase 2 Safety Lead-in: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | From signing of the informed consent form (ICF) through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2) | Adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence did not necessarily have a causal relationship with this treatment. A TEAE was any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. |
| Primary | Phase 1b and Phase 2 Safety Lead-in: Number of Participants With Grade 3 or Higher TEAEs | From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2) | TEAEs Grades were evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0. (NCI CTCAE v5), where Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL). Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. |
| Primary | Phase 1b and Phase 2 Safety Lead-in: Number of Participants With Dose Limiting Toxicities (DLTs) | Cycle 1 (Cycle length is equal to [=] 21 days) | A DLT was defined as any of the following AEs that occurred in the escalation phase or in the combination safety lead-in phase during Cycle 1 unless they were considered by the investigator to be clearly unrelated to therapy with modakafusp alfa according to NCI CTCAE version 5.0. Any Grade 5 TEAE. Febrile neutropenia: Grade \>=3 or 4 neutropenia. Grade 4 thrombocytopenia. Grade \>=3 thrombocytopenia. Any Grade 3 immune-related AEs such as pericarditis, pneumonitis, cardiotoxicity, hepatitis, or neurotoxicity. Delay in the initiation of Cycle 2 by more than 14 days from the calculated start date due to a lack of adequate recovery of treatment-related hematological or nonhematologic toxicities. Any Grade \>=3 nonhematologic toxicity with some exception. Any Grade 2 nonhematologic toxicity that was considered by the investigator to be related to study drug and dose-limiting. |
| Primary | Phase 1b and Phase 2 Safety Lead-in: Number of Participants Reporting One or More Serious Adverse Event (SAEs) | From signing of the ICF through 30 days after last dose of study drug even if the participants start non-protocol systemic therapy (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2) | SAE was defined as any untoward medical occurrence that resulted in death; was life-threatening; required inpatient hospitalization or prolongation of an existing hospitalization; resulted in persistent or significant disability or incapacity; was a congenital anomaly/birth defect; was a medically important event that might not result in death, be immediately life-threatening, or required hospitalization, but might be considered serious when, on the basis of appropriate medical judgment, it might jeopardize the participant, required medical or surgical intervention to prevent one of the outcomes listed above, or involves suspected transmission via a medicinal product of an infectious agent. |
| Primary | Phase 1b and Phase 2 Safety Lead-in: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations | From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2) | TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. |
| Primary | Phase 2 Expansion: Overall Response Rate (ORR) Based on RECIST v1.1 | From the first dose of study drug up to end of treatment or end of study (up to 2 years) | ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm). PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Phase 1b: Maximum Tolerated Dose (MTD) of Modakafusp Alfa | Cycle 1 (Cycle length = 21 days) | The MTD was selected as the highest dose which has maximum probability of being in targeted toxicity interval. |
| Secondary | Phase 1b and Phase 2 Safety Lead-in: Recommended Phase 2 Dose (RP2D) for Single Agent (SA) Modakafusp Alfa in Phase 1b and in Combination With Pembrolizumab in Phase 2 Safety Lead-in | Cycle 1 (Cycle length = 21 days) | The RP2D of modakafusp alfa as a single agent or in combination with pembrolizumab was determined based on safety (including DLTs), pharmacokinetic and clinical data. DLT was graded according to CTCAE v5.0. |
| Secondary | Phase 2 Expansion: Number of Participants Reporting One or More TEAEs | From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 2 years 1 month) | AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence did not necessarily have a causal relationship with this treatment. A TEAE was any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. |
| Secondary | Phase 2 Expansion: Number of Participants With Grade 3 or Higher TEAEs | From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 2 years 1 month) | TEAEs Grades were evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0. (NCI CTCAE v5), where Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL). Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1b and Phase 2 Safety Lead-in: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | From signing of the informed consent form (ICF) through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2) | The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1b and Phase 2 Safety Lead-in: Number of Participants With Grade 3 or Higher TEAEs | From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2) | The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1b and Phase 2 Safety Lead-in: Number of Participants With Dose Limiting Toxicities (DLTs) | Cycle 1 (Cycle length is equal to [=] 21 days) | DLT evaluable analysis set included participants who received all Cycle 1 doses of modakafusp alfa or experience a DLT in Cycle 1 in the dose-escalation portion of the study; or participants who received all Cycle 1 doses of modakafusp alfa in combination with pembrolizumab or experience a DLT in Cycle 1 in the safety lead-in portion of the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1b and Phase 2 Safety Lead-in: Number of Participants Reporting One or More Serious Adverse Event (SAEs) | From signing of the ICF through 30 days after last dose of study drug even if the participants start non-protocol systemic therapy (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2) | The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1b and Phase 2 Safety Lead-in: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations | From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 1 year 1 month for Phase 1b and 2 years 1 month for Phase 2) | The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2 Expansion: Overall Response Rate (ORR) Based on RECIST v1.1 | From the first dose of study drug up to end of treatment or end of study (up to 2 years) | The response evaluable analysis set included participants with measurable disease at baseline and at least 1 post-treatment evaluation. | percentage of participants | NUMBER |
| SECONDARY | Phase 1b: Maximum Tolerated Dose (MTD) of Modakafusp Alfa | Cycle 1 (Cycle length = 21 days) | DLT evaluable analysis set included participants who received all Cycle 1 doses of modakafusp alfa or experience a DLT in Cycle 1 in the dose-escalation portion of the study. | milligrams per kilograms (mg/kg) | NUMBER |
| SECONDARY | Phase 1b and Phase 2 Safety Lead-in: Recommended Phase 2 Dose (RP2D) for Single Agent (SA) Modakafusp Alfa in Phase 1b and in Combination With Pembrolizumab in Phase 2 Safety Lead-in | Cycle 1 (Cycle length = 21 days) | The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa. | mg/kg | NUMBER |
| SECONDARY | Phase 2 Expansion: Number of Participants Reporting One or More TEAEs | From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 2 years 1 month) | The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 2 Expansion: Number of Participants With Grade 3 or Higher TEAEs | From signing of the ICF through 30 days after last dose of study drug or the start of subsequent anticancer therapy, whichever occurred first (up to 2 years 1 month) | The safety analysis set included all enrolled participants who received at least one dose (even incomplete) of modakafusp alfa. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group226
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1b and Phase 2 Safety Lead-in: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | 3 | Participants | ||
| Phase 1b and Phase 2 Safety Lead-in: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | 3 | Participants | ||
| Phase 1b and Phase 2 Safety Lead-in: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | 3 | Participants | ||
| Phase 1b and Phase 2 Safety Lead-in: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | 3 | Participants | ||
| Phase 1b and Phase 2 Safety Lead-in: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | 3 | Participants | ||
| Phase 1b and Phase 2 Safety Lead-in: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | 6 | Participants | ||
| Phase 1b and Phase 2 Safety Lead-in: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | 3 | Participants | ||
| Phase 1b and Phase 2 Safety Lead-in: Number of Participants With Grade 3 or Higher TEAEs | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | 2 | Participants | ||
| Phase 1b and Phase 2 Safety Lead-in: Number of Participants With Grade 3 or Higher TEAEs | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | 1 | Participants | ||
| Phase 1b and Phase 2 Safety Lead-in: Number of Participants With Grade 3 or Higher TEAEs | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | 2 | Participants |
1 to 10 of 226Source ClinicalTrials.gov
See all 226 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | 3 | |
| Overall Study | STARTED | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | 3 | |
| Overall Study | STARTED | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | 3 | |
| Overall Study | STARTED | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | 3 | |
| Overall Study | STARTED | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | 3 | |
| Overall Study | STARTED | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | 6 | |
| Overall Study | STARTED | Phase 2, Safety Lead-in: Modakafusp 1.0 mg/kg Alfa + Pembrolizumab 400 mg | 3 | |
| Overall Study | STARTED | Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | 9 | |
| Overall Study | STARTED | Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg | 12 | |
| Overall Study | STARTED | Phase 2, Expansion, Cohort III: Modakafusp Alfa + Pembrolizumab | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events1,557
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | 0 | 3 | |
| other | Abdominal pain | Gastrointestinal disorders | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | 0 | 3 | |
| other | Abdominal pain | Gastrointestinal disorders | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | 0 | 3 | |
| other | Abdominal pain | Gastrointestinal disorders | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | 0 | 3 | |
| other | Abdominal pain | Gastrointestinal disorders | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | 0 | 3 | |
| other | Abdominal pain | Gastrointestinal disorders | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | 1 | 6 | |
| other | Abdominal pain | Gastrointestinal disorders | Phase 2, Safety Lead-in: Modakafusp Alfa + Pembrolizumab | 0 | 3 | |
| other | Abdominal pain | Gastrointestinal disorders | Phase 2, Expansion, Cohort I: Modakafusp Alfa + Pembrolizumab | 0 | 9 | |
| other | Abdominal pain | Gastrointestinal disorders | Phase 2, Expansion, Cohort II: Modakafusp Alfa + Pembrolizumab | 0 | 12 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | 0 | 3 |
1 to 10 of 1,557Source ClinicalTrials.gov
See all 1,557 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | 1 | 3 |
| Total, all-cause mortality | Phase 1b, Dose Escalation: Modakafusp Alfa 0.2 mg/kg | 2 | 3 |
| Total, all-cause mortality | Phase 1b, Dose Escalation: Modakafusp Alfa 0.4 mg/kg | 2 | 3 |
| Total, all-cause mortality | Phase 1b, Dose Escalation: Modakafusp Alfa 0.75 mg/kg | 3 | 3 |
| Total, all-cause mortality | Phase 1b, Dose Escalation: Modakafusp Alfa 1.0 mg/kg | 3 | 3 |
| Total, all-cause mortality | Phase 1b, Dose Escalation: Modakafusp Alfa 1.5 mg/kg | 4 | 6 |
| Total, all-cause mortality | Phase 2, Safety Lead-in: Modakafusp Alfa + Pembrolizumab | 1 | 3 |
| Total, all-cause mortality | Phase 2, Expansion, Cohort I: Modakafusp Alfa + Pembrolizumab | 2 | 9 |
| Total, all-cause mortality | Phase 2, Expansion, Cohort II: Modakafusp Alfa + Pembrolizumab | 4 | 12 |
| Total, other adverse events | Phase 1b, Dose Escalation: Modakafusp Alfa 0.1 mg/kg | 3 | 3 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41445795 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg vs Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg: Phase 2 Expansion: Number of Participants With Grade 3 or Higher TEAEs | Trial comparisons |
Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg vs Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg: Phase 2 Expansion: Number of Participants Reporting One or More TEAEs | Trial comparisons |
Phase 2, Expansion, Cohort I: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg vs Phase 2, Expansion, Cohort II: Modakafusp Alfa 1.0 mg/kg + Pembrolizumab 400 mg: Phase 2 Expansion: Number of Participants Reporting One or More SAEs | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04157517
GET https://conductscience.org/api/trials/v1/NCT04157517/registered?page=2