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KEYNOTE 029

 
Safety and Tolerability of Pembrolizumab (MK-3475) + Pegylated Interferon Alpha-2b and Pembrolizumab+ Ipilimumab in Participants With Renal Cell Carcinoma
 
 Last updated: January 29, 2017
 STATUS: Ongoing, not recruiting (no longer accepting participants) (per ClinicalTrials.gov/NCT02089685)

WHO

is the trial for?

Patients with kidney cancer (Renal cell carcinoma, RCC) who currently meet the following criteria:

  • clear-cell component
  • advanced and/or metastatic disease
  • at least one prior systemic therapy for RCC
  • overall health status has to be good (ECOG 0 or 1)
  • adequate organ function
  • resolution of toxic effects (side effects) of the most recent prior therapy to Grade 1 and/or recovered from major surgery

WHAT

is the key question that this trial is attempting to answer?

This phase I/II study is being done to analyze the safety, tolerability, and efficacy of a new immunotherapy for renal cell carcinoma (RCC).

It investigates the combination of the immune-checkpoint inhibitor pembrolizumab plus interferon alpha-2b versus a combination of the two checkpoint inhibitors pembrolizumab and ipilimumab. The primary hypothesis is that these combinations will be sufficiently well-tolerated to permit further clinical investigation (phase III studies).

WHY

patients might want to participate?

This clinical trial offers patients an opportunity to access a new therapy that may be effective for kidney cancer. This trial will further support the research in kidney cancer and potentially help other patients with kidney cancer. The trial might or might not have benefit in your individual case. For more about the importance and benefits of joining clinical trials, please click here.

WHEN

will the trial be open?

The study is ongoing but not recruiting – approx. 343 patients worldwide are currently expected to participate.

WHERE

is the trial available?

The trial will be available in 9 cancer centers in the USA, Australia and New Zealand.
For a complete list of trial locations, please click here:
pdf Trial locations KEYNOTE 029 (289 KB)
 

STUDY

DESIGN

What does the study look like?

The trial for RCC patients is being done in two parts:
1. Part 1A aims to find the right dosage for the following Phase II.
2. Part 2 will evaluate the efficacy of the drug combinations given in 6-week cycles.

There will be 3 study arms (groups): all participating patients will be randomly divided (by a computer) in three groups. Please note that patients in all groups will receive an active medication. No patient receives a placebo.

Patients in one group will be assigned pembrolizumab (Keytruda) in combination with Pegylated Interferon Alpha-2b (PegIFN-2b).

Patients in group 2 will be treated with pembrolizumab (Keytruda) in combination with ipilimumab (Yervoy™).

Group 3 is assigned to a pembrolizumab (Keytruda) monotherapy.

  • pembrolizumab (Keytruda™) is a fully human monoclonal antibody targeting PD-1
  • pegylated Interferon Alpha-2b (PegIFN-2b) is an interferon
  • ipilimumab (Yervoy™) is a fully human monoclonal antibody targeting CTLA-4
keynote 029

1) Pembrolizumab + PegIFN-2b
Participants receive pembrolizumab intravenously every 3 weeks + PegIFN-2b subcutaneously once a week in each 6-week cycle.

2) Pembrolizumab + ipilimumab
Pembrolizumab intravenously at assigned dose every 3 weeks + ipilimumab intravenously at assigned dose every 3 weeks for a total of 12 weeks
3) Pembrolizumab alone
Pembrolizumab is given intravenously at assigned dose and schedule.

HOW

do I get more information?

Patient organisations supporting kidney cancer patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving kidney cancer patients. If there are no such organisations in your country, please email us for more information: This email address is being protected from spambots. You need JavaScript enabled to view it.

CONNECT

with other patients on this trial

If you want to connect with other patients considering or participating in this trial, you can find them here: List of organisations worldwide.

SHARE

your experience 

You want to share your experience on this trial?
Send us an e-mail to:This email address is being protected from spambots. You need JavaScript enabled to view it.
Note that your experience would be helpful for other patients and patient organisations.

RESULTS

of the study

No results are available at this time. Future results will be linked here.
Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.
 
Back to clinical trials overview: How can I find an IO clinical trial for my cancer?