Advanced or Metastatic Solid Malignancies
Conditions
Brief summary
A Study of Sitravatinib Alone or in Combination with Other Anticancer Therapies in Advanced or Metastatic Malignancies
Detailed description
Sitravatinib is a spectrum-selective receptor tyrosine kinase (RTK) inhibitor that inhibits several closely related RTKs including the TAM family (Tyro3/Axl/MERTK), VEGFR2, KIT, and MET. The current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial.
Interventions
DRUGSitravatinib
Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
DRUGNivolumab
Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
DRUGPembrolizumab
Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody
DRUGEnfortumab Vedotin-Ejfv
Enfortumab is a Nectin-4 directed antibody-drug conjugate (ADC) comprised of a monoclonal antibody conjugated to the small molecule microtubule disrupting agent, monomethyl auristatin E (MMAE)
DRUGIpilimumab
Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody
Sponsors
Mirati Therapeutics Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Currently receiving sitravatinib single- agent or in combination with other therapeutic agent(s) in another Mirati- sponsored protocol * Currently tolerating the treatment regimen in the parent protocol * Experiencing clinical benefit with or without prior radiographic progression from the treatment regimen in the parent protocol in the opinion of the investigator and the investigator determines that continuing treatment is in the patient's best interest
Exclusion criteria
* Known or suspected presence of other cancer * Other life- threatening illness or organ system dysfunction compromising safety evaluation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Related Adverse Events. | Approximately up to 80.5 weeks | An AE is any reaction, side effect or other undesirable medical event that occurs during participation in a clinical trial, regardless of treatment group or suspected causal relationship to study treatment. Assessment of AEs will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE, Version 5.0\]), timing, seriousness, and relatedness to study treatment. A treatment-emergent AE (TEAE) is an AE that occurs after the first dose of any study treatment or any pre-existing condition that increases in severity after the first dose of study treatment. |
| Number of Participants With Treatment Related Adverse Events Which Lead to Study Drug Discontinuation | Approximately up to 80.5 weeks | Number of participants with treatment related adverse events which lead to study drug discontinuation. |
| Number of Participants With Clinically Significant Laboratory Abnormalities | Approximately up to 80.5 weeks | An abnormal laboratory test result should be reported as an AE in the CRF only if it is associated with one or more of the following: * Clinical symptoms; * Requires additional tests (beyond repeats), treatment, or intervention; * Results in change in study treatment dosing; * Requires discontinuation from study treatment; and/or * Considered by the investigator or sponsor to be an AE. |
Countries
United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Participant flow
Pre-assignment details
49 Participants enrolled and treated from 6 different parent studies
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 13.91 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 39 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 6 | 0 / 4 | 3 / 14 | 0 / 3 | 4 / 21 | 0 / 1 |
| other Total, other adverse events | 6 / 6 | 4 / 4 | 14 / 14 | 3 / 3 | 21 / 21 | 1 / 1 |
| serious Total, serious adverse events | 1 / 6 | 0 / 4 | 5 / 14 | 1 / 3 | 10 / 21 | 0 / 1 |
Outcome results
None listed