Trial · NCT04985604
Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors
NCT04985604, Phase 2, Terminated, Day One Biopharmaceuticals, Inc.; results first posted 2025-10-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors. Trials, record NCT04985604. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04985604
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors
- NCT number
- NCT04985604
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- Day One Biopharmaceuticals, Inc.
- Conditions
Melanoma, Solid Tumor, CRAF Gene Amplification, RAF1 Gene Amplification, BRAF Gene Fusion, BRAF Fusion, CRAF Gene Fusion, CRAF Fusion, RAF1 Gene Fusion, RAF1 Fusion, Thyroid Cancer, Papillary, Spitzoid Melanoma, Pilocytic Astrocytoma, Pilocytic Astrocytoma, Adult, Non Small Cell Lung Cancer, Non-Small Cell Adenocarcinoma, Colorectal Cancer, Pancreatic Acinar Carcinoma, Spitzoid Malignant Melanoma, Bladder Cancer, Bladder Urothelial Carcinoma, MAP Kinase Family Gene Mutation, RAF Mutation
- Interventions
- Tovorafenib
- First posted
- 2021-08-02
- Last updated
- 2025-10-02
- Other registries' IDs
- eudract:2021-003768-29
- Results first posted
- 2025-10-02
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) by the Investigator | Up to 23 months | ORR was defined as the percentage of participants with the best overall confirmed response of complete response (CR) or partial response (PR) according to the appropriate response assessment criteria including Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) for the disease setting as assessed by the Investigator. CR or PR was confirmed at a subsequent scan (\>=4 weeks) if the criteria for each are met . The exact 95% confidence intervals (CIs) were calculated using Clopper-Pearson method. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to 23 months | An adverse event (AE) is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. An AE is considered to be treatment-emergent if it has a start date/time on or after the first administration of study drug until 30 days after the last dose of study drug and before the start of subsequent therapy, whichever comes earlier. The distribution of AEs was analyzed by the type, frequency and severity for TEAEs. |
| Secondary | Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-baseline Relative to Baseline | Baseline and up to 23 months | Blood samples were collected for the analysis of following hematology parameters: anemia, neutrophil count decreased and white blood cell decreased. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G2, G3, and G4 are presented. The laboratory parameters were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5. |
| Secondary | Number of Participants With Worst Case Chemistry Results by Maximum Grade Increase Post-baseline Relative to Baseline | Baseline and up to 23 months | Blood samples were collected for the analysis of following chemistry parameters: creatine phosphokinase (CPK) increased, hypokalemia, hypoalbuminemia, hypercalcemia, hypocalcemia and hyponatremia. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G2, G3, and G4 are presented. The laboratory parameters were graded according to CTCAE version 5. |
| Secondary | Duration of Response (DOR) in Participants With Best Overall Response | Up to 23 months | Duration of response was defined as the interval from the date of the first documentation of tumor response (CR or PR) that was subsequently confirmed by investigator assessment to the date of first occurrence of radiographic disease progression based on RECIST 1.1 or RANO criteria or death due to any cause, whichever occurs earlier. DOR was estimated using Kaplan-Meier method. |
| Secondary | Duration of Progression Free Survival | Up to 23 months | Progression free survival was defined as the interval from the date of the first dose to the first occurrence of radiographic disease progression based on RECIST 1.1 or RANO criteria or death due to any cause, whichever occurs earlier. Progression free survival was estimated using Kaplan-Meier method. |
| Secondary | Duration of Overall Survival | Up to 23 months | Overall survival is defined as the interval from the date of the first dose until the recorded date of death due to any cause. Overall survival was estimated using Kaplan-Meier method. |
| Secondary | Time to Response | Up to 23 months | Time to Response was defined in participants with best overall response of complete response or partial response as determined by Investigator. It is the interval from the date of the first dose to date of first documentation of tumor response that was subsequently confirmed by investigator assessment. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) by the Investigator | Up to 23 months | Efficacy Analysis Set comprises of all participants who received at least one dose of study drug and have measurable disease as determined by the Investigator at baseline. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to 23 months | Safety Analysis Set comprises of all patients enrolled in the study who receive at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-baseline Relative to Baseline | Baseline and up to 23 months | Safety Analysis Set comprises of all patients enrolled in the study who receive at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Worst Case Chemistry Results by Maximum Grade Increase Post-baseline Relative to Baseline | Baseline and up to 23 months | Safety Analysis Set comprises of all patients enrolled in the study who receive at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) in Participants With Best Overall Response | Up to 23 months | Participants in the Efficacy Analysis Set who have a confirmed response of CR or PR. | Months | MEDIAN |
| SECONDARY | Duration of Progression Free Survival | Up to 23 months | Efficacy Analysis Set comprises of all participants who received at least one dose of study drug and have measurable disease as determined by the Investigator at baseline. | Months | MEDIAN |
| SECONDARY | Duration of Overall Survival | Up to 23 months | Efficacy Analysis Set comprises of all participants who received at least one dose of study drug and have measurable disease as determined by the Investigator at baseline. | Months | MEDIAN |
| SECONDARY | Time to Response | Up to 23 months | Participants in the Efficacy Analysis Set who have a confirmed response of CR or PR were analyzed. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group84
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) by the Investigator | Melanoma Cohort | 50.0 | 95% Confidence Interval 15.7 to 84.3 | Percentage of participants | |
| Overall Response Rate (ORR) by the Investigator | Tissue Agnostic Cohort | 40.0 | 95% Confidence Interval 16.3 to 67.7 | Percentage of participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Melanoma Cohort | Any TEAE | 8 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Tissue Agnostic Cohort | Any TEAE | 15 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Melanoma Cohort | TEAEs Related to Study Drug | 8 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Tissue Agnostic Cohort | TEAEs Related to Study Drug | 13 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Melanoma Cohort | Any serious TEAE | 2 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Tissue Agnostic Cohort | Any serious TEAE | 8 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Melanoma Cohort | Serious TEAEs Related to Study Drug | 0 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Tissue Agnostic Cohort | Serious TEAEs Related to Study Drug | 1 | Participants |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Melanoma Cohort | 8 | |
| Overall Study | STARTED | Tissue Agnostic Cohort | 15 | |
| Overall Study | COMPLETED | Melanoma Cohort | 4 | |
| Overall Study | COMPLETED | Tissue Agnostic Cohort | 8 | |
| Overall Study | NOT COMPLETED | Melanoma Cohort | 4 | |
| Overall Study | NOT COMPLETED | Tissue Agnostic Cohort | 7 |
Source ClinicalTrials.gov
Adverse events256
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 | Constipation | Gastrointestinal disorders | Melanoma Cohort | 3 | 8 | |
| other | Constipation | Gastrointestinal disorders | Tissue Agnostic Cohort | 3 | 15 | |
| other | Vomiting | Gastrointestinal disorders | Melanoma Cohort | 1 | 8 | |
| other | Vomiting | Gastrointestinal disorders | Tissue Agnostic Cohort | 4 | 15 | |
| other | Dyspepsia | Gastrointestinal disorders | Melanoma Cohort | 0 | 8 | |
| other | Dyspepsia | Gastrointestinal disorders | Tissue Agnostic Cohort | 3 | 15 | |
| other | Nausea | Gastrointestinal disorders | Melanoma Cohort | 0 | 8 | |
| other | Nausea | Gastrointestinal disorders | Tissue Agnostic Cohort | 2 | 15 | |
| other | Abdominal pain | Gastrointestinal disorders | Melanoma Cohort | 0 | 8 | |
| other | Abdominal pain | Gastrointestinal disorders | Tissue Agnostic Cohort | 2 | 15 |
1 to 10 of 256Source ClinicalTrials.gov
See all 256 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Melanoma Cohort | 4 | 8 |
| Total, all-cause mortality | Tissue Agnostic Cohort | 6 | 15 |
| Total, other adverse events | Melanoma Cohort | 8 | 8 |
| Total, other adverse events | Tissue Agnostic Cohort | 15 | 15 |
| Total, serious adverse events | Melanoma Cohort | 2 | 8 |
| Total, serious adverse events | Tissue Agnostic Cohort | 8 | 15 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42826365 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Melanoma Cohort vs Tissue Agnostic Cohort: deaths from any cause | Trial comparisons |
| Melanoma Cohort vs Tissue Agnostic Cohort: serious adverse events | 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.
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