⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma

Official Title: A Study of Safety, Tolerability, and Clinical Activity of Durvalumab and Tremelimumab Administered as Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Subjects With Advanced Hepatocellular Carcinoma

Study ID: NCT02519348

Study Description

Brief Summary: This is a multicenter, open-label, stratified, randomized study to evaluate the safety, tolerability, antitumor activity, pharmacokinetics, pharmacodynamics, and immunogenicity of durvalumab or tremelimumab monotherapy, or durvalumab in combination with tremelimumab or bevacizumab in advanced hepatocellular carcinoma.

Detailed Description: The study will comprise of 6 parts. Participants in Part 1A (safety run-in cohort), Part 1B (efficacy-gating cohort), Part 2A, and Part 4 will receive weight-based dosing regimens; and participants in Part 2B and Part 3 will receive fixed dosing regimens. Part 1A Stage 2 of the study may start after the first 3 participants in Stage 1 have been observed on study for at least 4 weeks. In addition, a separate cohort of participants will be enrolled in mainland China (China cohort) once global recruitment in Part 2A will be closed. * In Part 1 (both 1A and 1B), participants will receive tremelimumab 1 mg/kg intravenous (IV) every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W. * In Part 2A, participants will be randomized in a 1:1:1 ratio to receive: * Durvalumab 20 mg/kg Q4W * Tremelimumab 10 mg/kg Q4W × 7 doses followed by every 12 weeks (Q12W) * Tremelimumab 1 mg/kg Q4W × 4 doses + durvalumab 20 mg/kg Q4W, followed by durvalumab 20 mg/kg Q4W * In China cohort, Part 2A study design will be followed. * In Part 2B, participants will receive tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W. * In Part 3, participants will be randomized in a 2:2:1:2 ratio to receive: * Durvalumab 1500 mg Q4W * Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W * Tremelimumab 750 mg Q4W for 7 doses followed by Q12W * Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W, followed by durvalumab 1500 mg Q4W. Following protocol amendment 5, enrollment into 'Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg' arm will close. Participants will be randomized at a ratio of 2:1:2 in 'Durvalumab 1500 mg Q4W', 'Tremelimumab 750 mg Q4W for 7 doses followed by Q12W', and 'Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W' arms, respectively. • In Part 4, participants will receive durvalumab 1120 mg (15 mg/kg) + bevacizumab 15 mg/kg every 3 weeks (Q3W). Participants will receive the treatment until confirm progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first. All participants will be followed for survival until the end of study visit (last participant discontinues the study treatment).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Research Site, Phoenix, Arizona, United States

Research Site, San Francisco, California, United States

Research Site, New Haven, Connecticut, United States

Research Site, Jacksonville, Florida, United States

Research Site, Tampa, Florida, United States

Research Site, Indianapolis, Indiana, United States

Research Site, Boston, Massachusetts, United States

Research Site, New York, New York, United States

Research Site, Stony Brook, New York, United States

Research Site, Durham, North Carolina, United States

Research Site, Portland, Oregon, United States

Research Site, Philadelphia, Pennsylvania, United States

Research Site, Philadelphia, Pennsylvania, United States

Research Site, Nashville, Tennessee, United States

Research Site, Dallas, Texas, United States

Research Site, Seattle, Washington, United States

Research Site, Hangzhou, , China

Research Site, Nanjing, , China

Research Site, Shanghai, , China

Research Site, Hong Kong, , Hong Kong

Research Site, Sha Tin, , Hong Kong

Research Site, Benevento, , Italy

Research Site, Milano, , Italy

Research Site, Roma, , Italy

Research Site, Chuo-ku, , Japan

Research Site, Kashiwa, , Japan

Research Site, Osakasayama-shi, , Japan

Research Site, Busan, , Korea, Republic of

Research Site, Jung-gu, , Korea, Republic of

Research Site, Seongnam-si, , Korea, Republic of

Research Site, Seoul, , Korea, Republic of

Research Site, Seoul, , Korea, Republic of

Research Site, Seoul, , Korea, Republic of

Research Site, Seoul, , Korea, Republic of

Research Site, Bukit Merah, , Singapore

Research Site, Singapore, , Singapore

Research Site, Singapore, , Singapore

Research Site, Barcelona, , Spain

Research Site, Barcelona, , Spain

Research Site, Cordoba, , Spain

Research Site, Pamplona, , Spain

Research Site, Kaohsiung City, , Taiwan

Research Site, Taipei, , Taiwan

Research Site, Taoyuan City, , Taiwan

Contact Details

Name: MedImmune, LLC MedImmune, LLC

Affiliation: MedImmune LLC

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: