Trial · NCT03606174
A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma
NCT03606174, Phase 2, Terminated, Mirati Therapeutics Inc.; results first posted 2023-08-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma. Trials, record NCT03606174. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03606174
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma
- NCT number
- NCT03606174
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 260 participants, actual
- Lead sponsor
- Mirati Therapeutics Inc.
- Conditions
- Urothelial Carcinoma, Urothelial Carcinoma Bladder, Urothelial Carcinoma Ureter, Urothelial Carcinoma of the Renal Pelvis and Ureter, Urothelial Carcinoma Urethra
- Interventions
- Sitravatinib, Nivolumab, Pembrolizumab, Enfortumab vedotin
- First posted
- 2018-07-30
- Last updated
- 2023-08-24
- Results first posted
- 2023-08-24
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Up to approximately 3 years | ORR was defined as the number of participants documented to have a confirmed investigator-assessed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must have decreased to normal size (short axis \< 10 mm). PR was defined as a greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. |
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | Day 1 up to approximately 3 years | An AE was defined as any reaction, side effect or other undesirable medical event that occurred during participation in a clinical trial, regardless of treatment group or suspected causal relationship to study treatment. Any clinically significant changes from baseline in laboratory results were recorded as AEs. |
| Secondary | Number of Participants Who Experienced a Serious Adverse Event (SAE) | Day 1 up to approximately 3 years | An SAE was defined as any event that resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/permanent damage (substantial disruption of the ability to conduct normal life functions), a congenital anomaly/birth defect, or may have jeopardized the participant and may have required medical or surgical intervention to prevent intensive treatment in an emergency room or at home (e.g. for allergic bronchospasm, blood dyscrasias or convulsions) that do not result in inpatient hospitalization, development of drug dependency or drug abuse. |
| Secondary | Number of Participants Who Experienced a Treatment-related Adverse Event | Day 1 up to approximately 3 years | A treatment-related adverse event was defined as an adverse event determined to have a possible causal relationship to the study treatment(s) by the investigator. An adverse event was defined as any reaction, side effect or other undesirable medical event that occurred during participation in a clinical trial. Any clinically significant changes from baseline in laboratory results were recorded as adverse events. |
| Secondary | Duration of Response (DOR) | Up to approximately 3 years | DOR was defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of objective progression of disease (PD) per RECIST V1.1, or to death due to any cause in the absence of documented PD. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must have decreased to normal size (short axis \< 10 mm). PR was defined as a greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm. Per the statistical analysis plan (SAP), Cohort 9 arms are grouped as pre-specified as there was never intent to compare efficacy endpoints across Cohort 9 dose levels. |
| Secondary | Clinical Benefit Rate (CBR) | Up to approximately 3 years | Clinical Benefit Rate (CBR) was defined as the number of participants documented to have a confirmed CR, PR, or stable disease (SD), per RECIST V1.1, documented during at least 1 on-study assessment. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must have decreased to normal size (short axis \< 10 mm). PR was defined as a greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. SD was defined as target lesions increasing by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds. |
| Secondary | Progression-Free Survival (PFS) | Up to approximately 3 years | PFS was defined as the time from date of first study treatment to first PD per RECIST V1.1, or death due to any cause in the absence of documented PD. |
| Secondary | 1-Year Survival Rate | 1 year | Survival was defined as the time from date of first study treatment to death due to any cause. Kaplan-Meier (product limit) estimates of the percentage of participants who died at 1-year was calculated to estimate the 1-year survival rate, defined as the percentage of participants alive at 1 year. Confidence Intervals were calculated based on Greenwood's formula. Participants who discontinued prior to 1-year were censored on the last date that they were known to be alive. For participants with no follow-up after first dose of study drug, survival rate was censored at the date of first dose (Day 1). |
| Secondary | Overall Survival (OS) | Up to approximately 3 years | OS was defined as the time from date of first study treatment to death due to any cause. |
| Secondary | Geometric Mean Blood Plasma Concentration of Sitravatinib | Cycle(C)1 Day(D)1 pre-dose, 30min, 2,4,6,7,8,24hr post-dose, C1D15 pre-dose, 30min,2,4,6,7,8,24hr post-dose, C2D1 pre-dose,7hr post-dose, C2D8,C3D1,C3D8,C5D1,C6D8 pre-dose (28 day cycles Cohorts 1-8, 21 day cycles Cohort 9) | Blood draws for analysis of blood plasma concentrations of sitravatinib were collected following electrocardiograms and assessment of vital signs. Concentration data below the limit of quantification were set to 0. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | Up to approximately 3 years | Measured in the Full Analysis Set, which included participants who received ≥ 1 dose of each study treatment drug (ie, ≥ 1 dose of both sitravatinib and nivolumab for Cohorts 1 to 8, or ≥ 1 dose each of sitravatinib, pembrolizumab, and enfortumab vedotin for Cohort 9). Per the statistical analysis plan (SAP), Cohort 9 arms are grouped as pre-specified as there was never intent to compare efficacy endpoints across Cohort 9 dose levels. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced an Adverse Event (AE) | Day 1 up to approximately 3 years | Measured in the safety population, which included all participants who received ≥ 1 dose of any study treatment (sitravatinib, nivolumab, pembrolizumab, or enfortumab vedotin). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced a Serious Adverse Event (SAE) | Day 1 up to approximately 3 years | Measured in the safety population, which included all participants who received ≥ 1 dose of any study treatment (sitravatinib, nivolumab, pembrolizumab, or enfortumab vedotin). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced a Treatment-related Adverse Event | Day 1 up to approximately 3 years | Measured in the safety population, which included all participants who received ≥ 1 dose of any study treatment (sitravatinib, nivolumab, pembrolizumab, or enfortumab vedotin). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) | Up to approximately 3 years | Measured in the Clinical Activity Evaluable Population-confirmed Response Subset, which included participants who achieved an objective response, received ≥1 dose of study treatment drug, had an evaluable baseline tumor assessment and ≥1 post-baseline tumor assessment. One participant in Cohort 6 who experienced a response wasn't included in DOR analysis because they didn't receive ≥1 dose of study treatment, have an evaluable baseline tumor assessment or ≥1 post-baseline tumor assessment. | months | MEDIAN |
| SECONDARY | Clinical Benefit Rate (CBR) | Up to approximately 3 years | Measured in the Full Analysis Set, which included participants who received ≥ 1 dose of each study treatment drug (ie, ≥ 1 dose of both sitravatinib and nivolumab for Cohorts 1 to 8, or ≥ 1 dose each of sitravatinib, pembrolizumab, and enfortumab vedotin for Cohort 9). Per the statistical analysis plan (SAP), Cohort 9 arms are grouped as pre-specified as there was never intent to compare efficacy endpoints across Cohort 9 dose levels. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-Free Survival (PFS) | Up to approximately 3 years | Measured in the Full Analysis Set, which included participants who received ≥ 1 dose of each study treatment drug (ie, ≥ 1 dose of both sitravatinib and nivolumab for Cohorts 1 to 8, or ≥ 1 dose each of sitravatinib, pembrolizumab, and enfortumab vedotin for Cohort 9). Per the statistical analysis plan (SAP), Cohort 9 arms are grouped as pre-specified as there was never intent to compare efficacy endpoints across Cohort 9 dose levels. | months | MEDIAN |
| SECONDARY | 1-Year Survival Rate | 1 year | Measured in the Full Analysis Set, which included participants who received ≥ 1 dose of each study treatment drug (ie, ≥ 1 dose of both sitravatinib and nivolumab for Cohorts 1 to 8, or ≥ 1 dose each of sitravatinib, pembrolizumab, and enfortumab vedotin for Cohort 9). Per the statistical analysis plan (SAP), Cohort 9 arms are grouped as pre-specified as there was never intent to compare efficacy endpoints across Cohort 9 dose levels. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Up to approximately 3 years | Measured in the Full Analysis Set, which included participants who received ≥ 1 dose of each study treatment drug (ie, ≥ 1 dose of both sitravatinib and nivolumab for Cohorts 1 to 8, or ≥ 1 dose each of sitravatinib, pembrolizumab, and enfortumab vedotin for Cohort 9). Per the statistical analysis plan (SAP), Cohort 9 arms are grouped as pre-specified as there was never intent to compare efficacy endpoints across Cohort 9 dose levels. | months | MEDIAN |
| SECONDARY | Geometric Mean Blood Plasma Concentration of Sitravatinib | Cycle(C)1 Day(D)1 pre-dose, 30min, 2,4,6,7,8,24hr post-dose, C1D15 pre-dose, 30min,2,4,6,7,8,24hr post-dose, C2D1 pre-dose,7hr post-dose, C2D8,C3D1,C3D8,C5D1,C6D8 pre-dose (28 day cycles Cohorts 1-8, 21 day cycles Cohort 9) | Measured in the Pharmacokinetic (PK) Evaluable Population, which included all participants who received treatment with sitravatinib and had available data at each timepoint. Per the statistical analysis plan (SAP), Cohort 9 arms are grouped as pre-specified as there was never intent to compare PK endpoints across Cohort 9 dose levels. | ng/mL | GEOMETRIC_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group227
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Cohort 1 | 6 | Participants | ||
| Objective Response Rate (ORR) | Cohort 2 | 5 | Participants | ||
| Objective Response Rate (ORR) | Cohort 3 | 4 | Participants | ||
| Objective Response Rate (ORR) | Cohort 4 | 0 | Participants | ||
| Objective Response Rate (ORR) | Cohort 5 | 17 | Participants | ||
| Objective Response Rate (ORR) | Cohort 6 | 9 | Participants | ||
| Objective Response Rate (ORR) | Cohort 7 | 3 | Participants | ||
| Objective Response Rate (ORR) | Cohort 8 | 0 | Participants | ||
| Objective Response Rate (ORR) | Cohort 9 | 4 | Participants | ||
| Number of Participants Who Experienced an Adverse Event (AE) | Cohort 1 | 49 | Participants |
1 to 10 of 227Source ClinicalTrials.gov
See all 227 results by groupParticipant flow55
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 49 | |
| Overall Study | STARTED | Cohort 2 | 23 | |
| Overall Study | STARTED | Cohort 3 | 18 | |
| Overall Study | STARTED | Cohort 4 | 9 | |
| Overall Study | STARTED | Cohort 5 | 53 | |
| Overall Study | STARTED | Cohort 6 | 27 | |
| Overall Study | STARTED | Cohort 7 | 56 | |
| Overall Study | STARTED | Cohort 8 | 9 | |
| Overall Study | STARTED | Cohort 9 Dose Level 1 | 8 | |
| Overall Study | STARTED | Cohort 9 Dose Level 2 | 4 |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 participant flowAdverse events3,586
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 | Anaemia | Blood and lymphatic system disorders | Cohort 1 | 13 | 49 | 27 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2 | 10 | 23 | 14 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 3 | 2 | 18 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 4 | 2 | 9 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 5 | 10 | 53 | 21 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 6 | 10 | 27 | 27 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 7 | 10 | 56 | 18 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 8 | 1 | 9 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 9 Dose Level 1 | 2 | 8 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 9 Dose Level 2 | 1 | 4 | 2 |
1 to 10 of 3,586Source ClinicalTrials.gov
See all 3,586 adverse eventsAdverse event totals33
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | 37 | 49 |
| Total, all-cause mortality | Cohort 2 | 15 | 23 |
| Total, all-cause mortality | Cohort 3 | 15 | 18 |
| Total, all-cause mortality | Cohort 4 | 7 | 9 |
| Total, all-cause mortality | Cohort 5 | 35 | 53 |
| Total, all-cause mortality | Cohort 6 | 12 | 27 |
| Total, all-cause mortality | Cohort 7 | 36 | 56 |
| Total, all-cause mortality | Cohort 8 | 8 | 9 |
| Total, all-cause mortality | Cohort 9 Dose Level 1 | 5 | 8 |
| Total, all-cause mortality | Cohort 9 Dose Level 2 | 3 | 4 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03606174
GET https://conductscience.org/api/trials/v1/NCT03606174/results?page=2