A Phase 2 interventional study of CRS-207 and Pembrolizumab in Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma and Esophageal Adenocarcinoma, sponsored by Aduro Biotech, Inc.. Terminated at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-04.
Sponsored by Aduro Biotech, Inc. · Phase 2, Interventional, and Treatment
The purpose of this study is to determine whether CRS-207 in combination with pembrolizumab is safe and effective in adults with recurrent or metastatic gastric, gastroesophageal junction, or esophageal cancer who have received one or two prior chemotherapy regimens for advanced disease.
2,004 studies on the registry are indexed under Adenocarcinoma; 374 are open to participants now.
This study's enrollment of 5 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Aduro Biotech, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Diagnosis with confirmed histology of one or more of the following:
Exclusion Criteria:
CRS-207 and pembrolizumab will be administered in 3-week cycles. For Cycle 1, pembrolizumab (200 mg) will be administered by intravenous (IV) infusion over 30 minutes on Day 1 and CRS-207 (starting dose 1 × 10e9 colony-forming units \[CFU\]) will be administered by IV infusion over 1 hour on Day 2. If the infusions are well tolerated, pembrolizumab and CRS-207 may be administered on the same day (Day 1) for subsequent cycles. After 4 cycles, pembrolizumab will continue to be administered on Day 1 at each treatment cycle (every 3 weeks); CRS-207 will be administered once every 6 weeks (every other cycle). Treatment will continue for up to 35 cycles as long as there is adequate safety and potential for clinical benefit.
Biological: CRS-207 · Biological: Pembrolizumab
Administered by IV infusion over 1 hour.
Administered by IV infusion over 30 minutes.
Also known as: MK-3475
Objective Response Rate (ORR)
ORR was evaluated based upon the best overall response (BOR) for individual study subjects. BOR was determined by the highest post-baseline qualitative response value for each evaluable subject as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and given the following hierarchy of overall response results: complete response (CR) \> partial response (PR) \> stable disease (SD) \> progressive disease (PD) \> not evaluable (NE). The protocol-specified ORR was defined as the percentage of evaluable subjects with a BOR of CR or PR; however, this percentage was not calculated per the final study Statistical Analysis Plan (SAP). Therefore, the number of evaluable subjects with BOR RECIST v1.1 values of CR, PR, SD, PD, and NE are provided for this outcome measure. .
Time frame: BOR was assessed from the first post-baseline tumor assessment until documented disease progression, starting of a new cancer treatment, death, or study termination, whichever is earlier, assessed up to 15 weeks.
Disease Control Rate (DCR)
The percentage of evaluable subjects who exhibited a post-baseline tumor assessment BOR rating of CR, PR, or SD per RECIST v1.1.
Time frame: BOR was assessed from the first post-baseline tumor assessment until documented disease progression, starting of a new cancer treatment, death, or study termination, whichever is earlier, assessed up to 15 weeks.
Progression-Free Survival (PFS)
Number of weeks from the date of first dose of study treatment to the first date of objectively determined progressive disease (PD) according to RECIST v1.1 or death from any cause, estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs). Subjects who do not experience PD and are alive on or before the data cut-off date will be censored at the time of last evaluable tumor assessment or data cut-off date, whichever is earlier.
Time frame: Subjects followed for disease progression from first dose of study treatment until documented disease progression, initiation of new cancer treatment, death, or study termination, whichever is earlier, assessed up to 15 weeks.
Duration of Response (DOR)
Number of weeks from the first date a study subject achieved an objective disease response of CR or PR according to RECIST v1.1 to the date a study subject exhibited PD or death due to any cause, estimated using KM methods with 95% CIs. Subjects who do not experience PD or death at the time of analysis will be censored at the time of last evaluable tumor assessment or data cut-off date, whichever is earlier.
Time frame: DOR assessed from the date of a post-baseline tumor assessment of CR or PR per RECIST v1.1 until the date of documented disease progression, starting of a new cancer treatment, death, or study termination, whichever is earlier, assessed up to 15 weeks.
Overall Survival (OS)
Number of weeks from the date of first dose of study treatment to the date of death from any cause, estimated using KM methods with 95% CIs for subjects in the SAF. Subjects without documentation of death at the time of analysis were censored as of the date the subject was last known to be alive, or the data cut-off date, whichever is earlier.
Time frame: OS was assessed from the first dose of study treatment until death or study termination, whichever is earlier, assessed up to 15 weeks.
| Milestone | CRS-207 + Pembrolizumab |
|---|---|
| Started | 5 |
| Completed | 0 |
| Not completed | 5 |
| Withdrew: Death | 2 |
| Withdrew: Progression - subject went into hospice | 1 |
| Withdrew: Study terminated by sponsor | 2 |
ORR was evaluated based upon the best overall response (BOR) for individual study subjects. BOR was determined by the highest post-baseline qualitative response value for each evaluable subject as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and given the following hierarchy of overall response results: complete response (CR) \> partial response (PR) \> stable disease (SD) \> progressive disease (PD) \> not evaluable (NE). The protocol-specified ORR was defined as the percentage of evaluable subjects with a BOR of CR or PR; however, this percentage was not calculated per the final study Statistical Analysis Plan (SAP). Therefore, the number of evaluable subjects with BOR RECIST v1.1 values of CR, PR, SD, PD, and NE are provided for this outcome measure. .
| Participants | CRS-207 + Pembrolizumab |
|---|---|
| Complete Response | 0 |
| Partial Response | 0 |
| Stable Disease | 0 |
| Progressive Disease | 3 |
| Not Evaluable | 0 |
The percentage of evaluable subjects who exhibited a post-baseline tumor assessment BOR rating of CR, PR, or SD per RECIST v1.1.
| Participants | CRS-207 + Pembrolizumab |
|---|---|
| Disease Control Rate (DCR) | 0 |
Number of weeks from the date of first dose of study treatment to the first date of objectively determined progressive disease (PD) according to RECIST v1.1 or death from any cause, estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs). Subjects who do not experience PD and are alive on or before the data cut-off date will be censored at the time of last evaluable tumor assessment or data cut-off date, whichever is earlier.
| weeks | CRS-207 + Pembrolizumab |
|---|---|
| Progression-Free Survival (PFS) | 5.43 (0.14 to 6.00) |
Number of weeks from the first date a study subject achieved an objective disease response of CR or PR according to RECIST v1.1 to the date a study subject exhibited PD or death due to any cause, estimated using KM methods with 95% CIs. Subjects who do not experience PD or death at the time of analysis will be censored at the time of last evaluable tumor assessment or data cut-off date, whichever is earlier.
| Participants | CRS-207 + Pembrolizumab |
|---|---|
| Duration of Response (DOR) | 0 |
Number of weeks from the date of first dose of study treatment to the date of death from any cause, estimated using KM methods with 95% CIs for subjects in the SAF. Subjects without documentation of death at the time of analysis were censored as of the date the subject was last known to be alive, or the data cut-off date, whichever is earlier.
| weeks | CRS-207 + Pembrolizumab |
|---|---|
| Overall Survival (OS) | 11.57 (4.00 to 14.43) |
Collected over Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study treatment until 28 days following the last dose of study drug or until the subject initiates a new cancer therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for at least 12 months after end-of-treatment (EOT), or until death, loss to follow-up, or study termination, whichever is earlier, an average of 10 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CRS-207 + Pembrolizumab | 3/5 (60%) | 4/5 (80%) | 5/5 (100%) |
| Event | CRS-207 + Pembrolizumab |
|---|---|
| Obstruction GastricGastrointestinal disorders | 1/5 |
| Hepatic FailureHepatobiliary disorders | 1/5 |
| BacteraemiaInfections and infestations | 1/5 |
| Hepatic EncephalopathyNervous system disorders | 1/5 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 1/5 |
| Event | CRS-207 + Pembrolizumab |
|---|---|
| ChillsGeneral disorders | 4/5 |
| PyrexiaGeneral disorders | 4/5 |
| Decreased AppetiteMetabolism and nutrition disorders | 4/5 |
| FatigueGeneral disorders | 3/5 |
| Oedema PeripheralGeneral disorders | 2/5 |
| VomitingGastrointestinal disorders | 2/5 |
| Nasal CongestionRespiratory, thoracic and mediastinal disorders | 2/5 |
| HypertensionVascular disorders | 2/5 |
| PainGeneral disorders | 1/5 |
| Abdominal Pain UpperGastrointestinal disorders | 1/5 |
Baseline characteristics provided for all subjects who were administered at least 1 dose of protocol-specified drug (the Safety Analysis Set \[SAF\]).
| Age, Categorical(Participants) | CRS-207 + Pembrolizumab |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 4 |
| >=65 years | 1 |
| Age, Continuous(years) | CRS-207 + Pembrolizumab |
|---|---|
| Mean | 58.6 ± 13.05 |
| Sex: Female, Male(Participants) | CRS-207 + Pembrolizumab |
|---|---|
| Female | 2 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | CRS-207 + Pembrolizumab |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | CRS-207 + Pembrolizumab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
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Aduro Biotech, Inc.