Pembrolizumab 200 mg IV every 3 weeks plus, Bavituximab 3mg/kg IV weekly

Hepatocellular Carcinoma

Pembroluzumab 200mg IV once every 3 weeks

Pembrolizumab

Bavituximab

University of Texas Southwestern Medical Center

A Study of Pembrolizumab and Bavituximab in Patients With Advanced Hepatocellular Carcinoma

A Phase II Study of Pembrolizumab and Bavituximab in Patients With Advanced Hepatocellular Carcinoma

To determine the overall response rate (ORR) of combination pembrolizumab and bavituximab in patients with advanced HCC.

To determine overall survival, 6-month progression free survival, and duration of response of combination pembrolizumab and bavituximab compared to historical controls

To determine the safety and tolerability of combination pembrolizumab and bavituximab as measured by rates of adverse events according to the CTCAE

To determine treatment response with pre- and intra-treatment biopsies and plasma/serum. Correlative studies will be performed on the collected tissue and blood samples to determine if predictive markers of response can be generated

Merck Sharp & Dohme Corp.

Locally advanced or metastatic HCC not amenable to locoregional therapy

Participants take 10 mg AR-42 orally per day on 3 non-consecutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously

Participants take 20 mg AR-42 orally per day on 3 non-consecutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously

Participants take 20 mg AR-42 orally per day on 3 non-consecutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 800mg orally daily continuously

Participants take 30 mg AR-42 orally per day on 3 non-consecutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 800mg orally daily continuously

Participants take 30 mg AR-42 orally per day on 3 non-consecutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously

Participants take 40 mg AR-42 orally per day on 3 non-consecutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 800mg orally daily continuously

Participants take 40 mg AR-42 orally per day on 3 non-consecutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously

Participants take 20 mg AR-42 orally per day on 3 non-consecutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously.

Cohort 1

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

To determine the recommended phase 2 doses (RP2Ds) for AR-42 and pazopanib that are the same as or less than the maximum tolerated doses (MTDs). The dose-limiting toxicity (DLT) evaluation period will be the first treatment cycle. Patients must have taken a minimum of 6 AR-42 doses and a minimum of 21 pazopanib doses during cycle 1 to be considered evaluable for DLT, if DLT has not been observed at the delivered dose. Patients' treatment dose level, dose modification, evaluability for DLT, and DLTs will be listed and summarized by basic descriptive statistics such as frequency and proportion. The maximum tolerated dose(MTDs)/recommended phase 2 doses (RP2Ds) will be found based on the criteria in the protocol.

Cohort Minus 1 (-1)

Participants take 20 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously

Participants take 20 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 800mg orally daily continuously

Cohort 2

Participants take 30 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 800mg orally daily continuously

Cohort 3A

Participants take 30 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously

Cohort 3B

Participants take 40 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 800mg orally daily continuously

Cohort 4A

Participants take 40 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously

Cohort 4B

The Recommended Phase 2 Doses (RP2Ds) of AR-42 and Pazopanib When Given in Combination.

The safety and toxicity of AR-42 and pazopanib when given in combination. Adverse Events (AEs) were characterized and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0) to determine the safety and toxicity of the combination of AR-42 and pazopanib. All AEs regardless of grade were recorded from the beginning of the study procedures through 30 days following the end of study treatment.

Number of Participants With Adverse Events That Were Related to Treatment, AR-42 and Pazopanib Combination.

Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI:
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

The Antitumor Effects of the AR-42 and Pazopanib Treatment Regimen in Patients With Advanced Renal Cell Carcinoma (RCC) or Soft Tissue Sarcoma (STS).

Overall Study

Andrew Poklepovic, MD

Renal Cell Carcinoma

Soft Tissue Sarcoma

Metastatic Disease

AR-42 tablets were taken orally once per day on 3 non-consecutive days during the first 3 weeks of each 4-week cycle. If treatment was interrupted during the cycle, the cycle was to be extended

AR-42

Pazopanib tablets were taken orally once daily continuously during each 4-week treatment cycle. There were no scheduled breaks in pazopanib therapy

lipase/mệt mỏi

A Study of Pembrolizumab and Bavituximab in Patients With Advanced Hepatocellular Carcinoma

Study of the Pan-DAC Inhibitor AR-42 and Pazopanib in Advanced Sarcoma and Kidney Cancer

Cơ sở dữ liệu đầy đủ nhất về dược liệu được hỗ trợ bởi khoa học