Trial Outcomes & Findings for Improving Response to Immunotherapy in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C Virus Infection With Direct-Acting Antiviral Therapy (NCT NCT05717400)

NCT ID: NCT05717400

Last Updated: 2024-12-31

Results Overview

Stable Disease in 2 out of 2 patients

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 2 participants
• Primary outcome timeframe: 9 months
• Results posted on: 2024-12-31

Participant Flow

Recruitment period was between 03/17/2023-08/29/2024 at MD Anderson Cancer Center

Participant milestones

Measure	Unblinded Open-label Single Arm Phase 4 Study atezolizumab (1200 mg) plus bevacizumab (15 mg per kilogram of body weight) intravenously every 3 weeks combined with any of the following DAA regimens: 1) sofosbuvir (400 mg) + velpatasvir (100 mg), or 2) sofosbuvir (400 mg) + velpatasvir (100 mg) + voxilaprevir (100 mg) administered once daily or twice daily, orally, for 12 weeks
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Response to Immunotherapy in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C Virus Infection With Direct-Acting Antiviral Therapy

Baseline characteristics by cohort

Measure	Unblinded Open-label Single Arm Phase 4 Study n=2 Participants atezolizumab (1200 mg) plus bevacizumab (15 mg per kilogram of body weight) intravenously every 3 weeks combined with any of the following DAA regimens: 1) sofosbuvir (400 mg) + velpatasvir (100 mg), or 2) sofosbuvir (400 mg) + velpatasvir (100 mg) + voxilaprevir (100 mg) administered once daily or twice daily, orally, for 12 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	1 Participants n=5 Participants
Race (NIH/OMB) White	1 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	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 9 months

Stable Disease in 2 out of 2 patients

Outcome measures

Measure	Unblinded Open-label Single Arm Phase 4 Study n=2 Participants atezolizumab (1200 mg) plus bevacizumab (15 mg per kilogram of body weight) intravenously every 3 weeks combined with any of the following DAA regimens: 1) sofosbuvir (400 mg) + velpatasvir (100 mg), or 2) sofosbuvir (400 mg) + velpatasvir (100 mg) + voxilaprevir (100 mg) administered once daily or twice daily, orally, for 12 weeks
Overall Response Rate	2 participants

PRIMARY outcome

Timeframe: 9 months

SVR 12 in 2 out of 2 patients

Outcome measures

Measure	Unblinded Open-label Single Arm Phase 4 Study n=2 Participants atezolizumab (1200 mg) plus bevacizumab (15 mg per kilogram of body weight) intravenously every 3 weeks combined with any of the following DAA regimens: 1) sofosbuvir (400 mg) + velpatasvir (100 mg), or 2) sofosbuvir (400 mg) + velpatasvir (100 mg) + voxilaprevir (100 mg) administered once daily or twice daily, orally, for 12 weeks
Sustained Virologic Response (SVR)	2 participants

Adverse Events

Unblinded Open-label Single Arm Phase 4 Study

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Unblinded Open-label Single Arm Phase 4 Study n=2 participants at risk atezolizumab (1200 mg) plus bevacizumab (15 mg per kilogram of body weight) intravenously every 3 weeks combined with any of the following DAA regimens: 1) sofosbuvir (400 mg) + velpatasvir (100 mg), or 2) sofosbuvir (400 mg) + velpatasvir (100 mg) + voxilaprevir (100 mg) administered once daily or twice daily, orally, for 12 weeks
General disorders Weakness	50.0% 1/2 • 1 year and 5 months Any grade 3-4 adverse events observed during the study period, one patient died because of progressive disease after follow-up period.
General disorders Edema	50.0% 1/2 • 1 year and 5 months Any grade 3-4 adverse events observed during the study period, one patient died because of progressive disease after follow-up period.
General disorders Anorexia	100.0% 2/2 • 1 year and 5 months Any grade 3-4 adverse events observed during the study period, one patient died because of progressive disease after follow-up period.
Blood and lymphatic system disorders Anemia	100.0% 2/2 • 1 year and 5 months Any grade 3-4 adverse events observed during the study period, one patient died because of progressive disease after follow-up period.
Metabolism and nutrition disorders Alt increase	50.0% 1/2 • 1 year and 5 months Any grade 3-4 adverse events observed during the study period, one patient died because of progressive disease after follow-up period.
Metabolism and nutrition disorders AST increase	50.0% 1/2 • 1 year and 5 months Any grade 3-4 adverse events observed during the study period, one patient died because of progressive disease after follow-up period.
Renal and urinary disorders Creatinine increased	50.0% 1/2 • 1 year and 5 months Any grade 3-4 adverse events observed during the study period, one patient died because of progressive disease after follow-up period.
Metabolism and nutrition disorders Alkaline phosphatase increased	50.0% 1/2 • 1 year and 5 months Any grade 3-4 adverse events observed during the study period, one patient died because of progressive disease after follow-up period.
Metabolism and nutrition disorders Hypoalbuminemia	50.0% 1/2 • 1 year and 5 months Any grade 3-4 adverse events observed during the study period, one patient died because of progressive disease after follow-up period.
General disorders Chills	50.0% 1/2 • 1 year and 5 months Any grade 3-4 adverse events observed during the study period, one patient died because of progressive disease after follow-up period.
General disorders Rhinorrhea (Runny nose)	50.0% 1/2 • 1 year and 5 months Any grade 3-4 adverse events observed during the study period, one patient died because of progressive disease after follow-up period.
General disorders Nausea	100.0% 2/2 • 1 year and 5 months Any grade 3-4 adverse events observed during the study period, one patient died because of progressive disease after follow-up period.
General disorders Pain (Abdominal, back, shoulder and neck)	50.0% 1/2 • 1 year and 5 months Any grade 3-4 adverse events observed during the study period, one patient died because of progressive disease after follow-up period.
General disorders Bone pain	50.0% 1/2 • 1 year and 5 months Any grade 3-4 adverse events observed during the study period, one patient died because of progressive disease after follow-up period.
General disorders Anxiety	50.0% 1/2 • 1 year and 5 months Any grade 3-4 adverse events observed during the study period, one patient died because of progressive disease after follow-up period.
General disorders Insomnia	50.0% 1/2 • 1 year and 5 months Any grade 3-4 adverse events observed during the study period, one patient died because of progressive disease after follow-up period.
General disorders Nervousness	50.0% 1/2 • 1 year and 5 months Any grade 3-4 adverse events observed during the study period, one patient died because of progressive disease after follow-up period.
General disorders Gait disturbance	50.0% 1/2 • 1 year and 5 months Any grade 3-4 adverse events observed during the study period, one patient died because of progressive disease after follow-up period.
Gastrointestinal disorders Constipation	100.0% 2/2 • 1 year and 5 months Any grade 3-4 adverse events observed during the study period, one patient died because of progressive disease after follow-up period.
General disorders Arthralgia	100.0% 2/2 • 1 year and 5 months Any grade 3-4 adverse events observed during the study period, one patient died because of progressive disease after follow-up period.
General disorders Mucositis	50.0% 1/2 • 1 year and 5 months Any grade 3-4 adverse events observed during the study period, one patient died because of progressive disease after follow-up period.
General disorders Fatigue	100.0% 2/2 • 1 year and 5 months Any grade 3-4 adverse events observed during the study period, one patient died because of progressive disease after follow-up period.
Renal and urinary disorders Proteinuria	100.0% 2/2 • 1 year and 5 months Any grade 3-4 adverse events observed during the study period, one patient died because of progressive disease after follow-up period.

Additional Information

Harrys A. Torres, MD

M D Anderson Cancer Center

Phone: (713) 792-6503

Email: htorres@mdanderson.org

Results disclosure agreements

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