Trial Outcomes & Findings for Neutron Radiation Therapy and Pembrolizumab in Treating Participants With Advanced Urothelial Carcinoma (NCT NCT03486197)

NCT ID: NCT03486197

Last Updated: 2024-11-20

Results Overview

Overall response rate will be calculated as the percentage of patients achieving a partial response or complete response.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 12 participants
• Primary outcome timeframe: Up to 1 year
• Results posted on: 2024-11-20

Participant Flow

Participant milestones

Measure	Treatment (Pembrolizumab, Neutron Radiation Therapy) Participants receive pembrolizumab IV on days 1 and 22. On day 23, participants may undergo an optional tumor biopsy and receive 3-5 treatments of neutron radiation therapy over 2 weeks on days 23-42. Participants receive pembrolizumab IV on day 43 and continue per standard of care in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Radiation Therapy: Undergo neutron radiation therapy
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neutron Radiation Therapy and Pembrolizumab in Treating Participants With Advanced Urothelial Carcinoma

Baseline characteristics by cohort

Measure	Treatment (Pembrolizumab, Neutron Radiation Therapy) n=12 Participants Participants receive pembrolizumab IV on days 1 and 22. On day 23, participants may undergo an optional tumor biopsy and receive 3-5 treatments of neutron radiation therapy over 2 weeks on days 23-42. Participants receive pembrolizumab IV on day 43 and continue per standard of care in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Radiation Therapy: Undergo neutron radiation therapy
Age, Continuous	71 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Overall response rate will be calculated as the percentage of patients achieving a partial response or complete response.

Outcome measures

Measure

Treatment (Pembrolizumab, Neutron Radiation Therapy) n=12 Participants Participants receive pembrolizumab IV on days 1 and 22. On day 23, participants may undergo an optional tumor biopsy and receive 3-5 treatments of neutron radiation therapy over 2 weeks on days 23-42. Participants receive pembrolizumab IV on day 43 and continue per standard of care in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Radiation Therapy: Undergo neutron radiation therapy

Overall Response Rate Per Immune-modified Response Evaluation Criteria in Solid Tumors

6 Participants

SECONDARY outcome

Timeframe: At 1 year

Final statistical analyses of OS will consist of Kaplan-Meier estimation.

Outcome measures

Measure

Treatment (Pembrolizumab, Neutron Radiation Therapy) n=12 Participants Participants receive pembrolizumab IV on days 1 and 22. On day 23, participants may undergo an optional tumor biopsy and receive 3-5 treatments of neutron radiation therapy over 2 weeks on days 23-42. Participants receive pembrolizumab IV on day 43 and continue per standard of care in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Radiation Therapy: Undergo neutron radiation therapy

Overall Survival

62 percentage of participants Interval 51.0 to 74.0

SECONDARY outcome

Timeframe: At 1 year

Final statistical analyses of PFS will consist of Kaplan-Meier estimation.

Outcome measures

Measure

Treatment (Pembrolizumab, Neutron Radiation Therapy) n=12 Participants Participants receive pembrolizumab IV on days 1 and 22. On day 23, participants may undergo an optional tumor biopsy and receive 3-5 treatments of neutron radiation therapy over 2 weeks on days 23-42. Participants receive pembrolizumab IV on day 43 and continue per standard of care in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Radiation Therapy: Undergo neutron radiation therapy

Progression-free Survival

55 percentage of participants Interval 41.0 to 68.0

Adverse Events

Treatment (Pembrolizumab, Neutron Radiation Therapy)

Serious events: 2 serious events

Other events: 9 other events

Deaths: 6 deaths

Serious adverse events

Measure	Treatment (Pembrolizumab, Neutron Radiation Therapy) n=12 participants at risk Participants receive pembrolizumab IV on days 1 and 22. On day 23, participants may undergo an optional tumor biopsy and receive 3-5 treatments of neutron radiation therapy over 2 weeks on days 23-42. Participants receive pembrolizumab IV on day 43 and continue per standard of care in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Radiation Therapy: Undergo neutron radiation therapy
Musculoskeletal and connective tissue disorders Myositis Grade 3	8.3% 1/12 • Number of events 1 • Adverse events were collected during radiation treatment weekly during physician visits, and during each pembrolizumab infusion with a physician visit for up to 1 year. CTCAE v4 was used to grade adverse events for up to 1 months after study enrollment.
Renal and urinary disorders Acute Kidney Injury Grade 3	8.3% 1/12 • Number of events 1 • Adverse events were collected during radiation treatment weekly during physician visits, and during each pembrolizumab infusion with a physician visit for up to 1 year. CTCAE v4 was used to grade adverse events for up to 1 months after study enrollment.

Other adverse events

Measure	Treatment (Pembrolizumab, Neutron Radiation Therapy) n=12 participants at risk Participants receive pembrolizumab IV on days 1 and 22. On day 23, participants may undergo an optional tumor biopsy and receive 3-5 treatments of neutron radiation therapy over 2 weeks on days 23-42. Participants receive pembrolizumab IV on day 43 and continue per standard of care in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV Radiation Therapy: Undergo neutron radiation therapy
General disorders Fatigue Grade 2	41.7% 5/12 • Number of events 5 • Adverse events were collected during radiation treatment weekly during physician visits, and during each pembrolizumab infusion with a physician visit for up to 1 year. CTCAE v4 was used to grade adverse events for up to 1 months after study enrollment.
Gastrointestinal disorders Gastritis Grade 2	16.7% 2/12 • Number of events 2 • Adverse events were collected during radiation treatment weekly during physician visits, and during each pembrolizumab infusion with a physician visit for up to 1 year. CTCAE v4 was used to grade adverse events for up to 1 months after study enrollment.
Gastrointestinal disorders Pancreatitis Grade 2	8.3% 1/12 • Number of events 1 • Adverse events were collected during radiation treatment weekly during physician visits, and during each pembrolizumab infusion with a physician visit for up to 1 year. CTCAE v4 was used to grade adverse events for up to 1 months after study enrollment.
Renal and urinary disorders Acute Kidney Injury Grade 2	8.3% 1/12 • Number of events 1 • Adverse events were collected during radiation treatment weekly during physician visits, and during each pembrolizumab infusion with a physician visit for up to 1 year. CTCAE v4 was used to grade adverse events for up to 1 months after study enrollment.

Additional Information

Dr. Jing Zeng

University of Washington/Fred Hutch Cancer Center Proton Therapy

Phone: 2065984110

Email: jzeng13@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place