A Phase II Randomized Open label Study of High Dose Interleukin 2 vs High Dose Interleukin 2 plus Entinostat in Untreated Advanced Renal Cell Carcinoma (GU17-289)

Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study

The purpose of this study is to compare any good and bad effects of using a high dose Interleukin (IL-2) and Entinostat to using IL-2 alone. The addition of Entinostat to high dose IL-2 could shrink your cancer/prevent it from returning for a longer period of time but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.

Detailed description of study

The purpose of this study is to estimate and compare progression free survival (PFS) in patients receiving high dose interleukin 2 or high dose interleukin 2 plus entinostat.
Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: renal cell carcinoma
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria
In order to be eligible to take part in this trial, patients must meet the following criteria:

  • Patients must have pathological diagnosis of renal cell carcinoma that is metastatic or surgically unresectable. The histology must be clear cell carcinoma or predominant clear cell carcinoma.
  • Up to two prior therapies for RCC are allowed. One prior therapy must contain an immune checkpoint inhibitor. Prior palliative radiation to metastatic lesion(s) is permitted, provided there is at least one measurable and/or evaluable lesion(s) that has not been irradiated.

For a full list of participation criteria, please visit clinicaltrials.gov.

Updated on 04 Aug 2024. Study ID: 1712301349

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