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Center for Global Research Data

Patterns of outcomes and the relevance surrogate endpoints in patients treated with immune checkpoint inhibitors.

Lead Investigator: David Hsieh, University of Texas Southwestern Medical Center
Title of Proposal Research: Patterns of outcomes and the relevance surrogate endpoints in patients treated with immune checkpoint inhibitors.
Vivli Data Request: 6008
Funding Source: Cancer Prevention and Research Institute of Texas
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Immune checkpoint inhibitors (ICIs) have revolutionized cancer therapy because of their ability to induce tolerable and durable responses in advanced cancers. This can be attributed to the unique mechanism by which ICIs trigger a person’s immune system to reject cancer cells. The effects of ICIs in patients are different from those observed with conventional chemotherapies. For instance, while chemotherapy typically causes cancer cell death resulting in detectable shrinkage of cancers, ICIs may stop or slow cancer growth for long periods without evidence of cancer cell death. In several small studies, patients treated with ICIs have also been noted to have prolonged lives despite their cancers growing during ICI treatment. The different patterns of responses observed in patients treated with ICIs are important to recognize as they guide expectations of treatment outcomes for patients and may inform the design of clinical trials studying ICIs. However, atypical responses to ICIs have not been consistently defined in past studies or only assessed at the level of trials. This is also of clinical relevance as surrogate endpoints, substitute measures of overall survival, are frequently used in ICI trials to determine the advancement of treatment testing or for FDA approval.

Our primary objective is to assess how objective response categories, progression-free survival (PFS), duration of response (DUR), time to best response (TTBR), and depth of response (DepOR) are associated/correlated with overall survival (OS) in patients treated with ICIs.

Requested Studies:

A Phase II, Multicenter, Single-Arm Study of Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
Data Contributor: Roche
Study ID: NCT02951767
Sponsor ID: GO29293 (Cohort 1)

A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma
Data Contributor: Roche
Study ID: NCT02420821
Sponsor ID: WO29637

A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer After Failure With Platinum-Containing Chemotherapy
Data Contributor: Roche
Study ID: NCT02302807
Sponsor ID: GO29294

A Phase II, Multicenter, Single-Arm Study of Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
Data Contributor: Roche
Study ID: NCT02108652
Sponsor ID: GO29293 (Cohort 2)

A Phase II, Multicenter, Single-Arm Study OF Atezolizumab In Patients With PD-L1-Positive Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02031458
Sponsor ID: GO28754

A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum Containing Chemotherapy
Data Contributor: Roche
Study ID: NCT02008227
Sponsor ID: GO28915

A Phase II, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Administered as Monotherapy or in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma
Data Contributor: Roche
Study ID: NCT01984242
Sponsor ID: WO29074

A Phase II, Open-label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of MPDL3280A (Anti−PD-L1 Antibody) Compared With Docetaxel in Patients With Non−Small Cell Lung Cancer After Platinum Failure
Data Contributor: Roche
Study ID: NCT01903993
Sponsor ID: GO28753

A Phase II, Multicenter, Single-arm Study of MPDL3280A in Patients With PD-L1-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT01846416
Sponsor ID: GO28625