Trial Outcomes & Findings for Anti-PD-L1 and SAbR for Ovarian Cancer (NCT NCT03312114)

Results Overview

Analysis of (with safety lead-in) trial of combined Avelumab (MSB0010718C) anti-PD-L1checkpoint blockade with SAbR for Recurrent Ovarian and peritoneal ,fallopian tube cancer (ROPT) is to assess overall clinical response rates per RECIST criteria .

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

1 year,4 months

Results posted on

2020-11-12

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm Avelumab and SABR Trial of combined Avelumab with SAbR for Recurrent Ovarian and peritoneal, fallopian tube cancer (ROPT) is to assess overall clinical response rates per RECIST criteria.
Overall Study STARTED	5
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm Avelumab and SABR Trial of combined Avelumab with SAbR for Recurrent Ovarian and peritoneal, fallopian tube cancer (ROPT) is to assess overall clinical response rates per RECIST criteria.
Overall Study All the five enrolled dropped out of the	5

Baseline Characteristics

Anti-PD-L1 and SAbR for Ovarian Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=5 Participants Avelumab and SABR Avelumab: Avelumab\* (MSB0010718C; anti-PD-L1 is a fully human anti-PD- L1 IgG1 antibody)
Age, Continuous	63 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year,4 months

Population: All patients progressed- without any response.

Analysis of (with safety lead-in) trial of combined Avelumab (MSB0010718C) anti-PD-L1checkpoint blockade with SAbR for Recurrent Ovarian and peritoneal ,fallopian tube cancer (ROPT) is to assess overall clinical response rates per RECIST criteria .

Outcome measures

Outcome measures
Measure	Recurrent Ovarian and Peritoneal ,Fallopian Tube Cancer (ROP n=5 Participants The primary objective of this phase II(with safety lead-in) trial of combined Avelumab (MSB0010718C) anti-PD-L1checkpoint blockade with SAbR for Recurrent Ovarian and peritoneal ,fallopian tube cancer (ROPT) is to assess overall clinical response rates per RECIST criteria . This will be after the safety lead-in is completed without DLT at 8 weeks from start of Avelumab, to evaluate the safety of Avelumab and SABR to an acceptable dose of the site radiated.
To Assess Overall Clinical Response Rates Per RECIST Criteria.	0 Participants

SECONDARY outcome

Timeframe: 1 year, 4 months

Population: All the five enrolled dropped out of the study early due to disease progression. Study was stopped because drug was found to be ineffective by the pharmaceutical company.

Patients were started on alternative therapy and were not followed after starting alternative therapy. Study was stopped because drug was found to be ineffective by the pharmaceutical company

Outcome measures

Outcome measures
Measure	Recurrent Ovarian and Peritoneal ,Fallopian Tube Cancer (ROP n=5 Participants The primary objective of this phase II(with safety lead-in) trial of combined Avelumab (MSB0010718C) anti-PD-L1checkpoint blockade with SAbR for Recurrent Ovarian and peritoneal ,fallopian tube cancer (ROPT) is to assess overall clinical response rates per RECIST criteria . This will be after the safety lead-in is completed without DLT at 8 weeks from start of Avelumab, to evaluate the safety of Avelumab and SABR to an acceptable dose of the site radiated.
Overall Survival	NA Participants All the five enrolled dropped out of the study early due to disease progression. Study was stopped because drug was found to be ineffective by the pharmaceutical company

Adverse Events

Concurrent Anti-PD-L1 + SAbR to Metastasis

Serious events: 0 serious events

Other events: 5 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Concurrent Anti-PD-L1 + SAbR to Metastasis n=5 participants at risk There were no serious adverse events on the trial.
Blood and lymphatic system disorders LYMPHOCYTE COUNT DECREASED	100.0% 5/5 • Number of events 7 • The adverse event were 6 months from enrollment
General disorders FATIGUE	100.0% 5/5 • Number of events 6 • The adverse event were 6 months from enrollment
Gastrointestinal disorders CONSTIPATION	100.0% 5/5 • Number of events 6 • The adverse event were 6 months from enrollment
General disorders ANOERXIA	100.0% 5/5 • Number of events 5 • The adverse event were 6 months from enrollment
General disorders VOMITING	100.0% 5/5 • Number of events 5 • The adverse event were 6 months from enrollment

Additional Information

Phase II trial of Concurrent Anti-PD-L1 and SAbR for Patients with Persistent or Recurrent Epithelia

University of Texas Southwestern Medical Center

Phone: (214) 645-7296

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place