Long-term Safety and Effectiveness Study for Participants with Advanced Tumors who are Currently on Treatment or in Follow-up in a Pembrolizumab Trial

Overview

About this study

The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who rollover into this extension study.

This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase.

Each participant will roll-over to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study.

Participants who were in the First Course Phase of study treatment in their parent study will enter the First Course Phase of this study and complete up to 35 cycles of study treatment with pembrolizumab or a pembrolizumab-based combination.

Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study.

Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 cycles of study treatment with pembrolizumab or a pembrolizumab-based combination.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Type of Participants
1. Participants that are currently enrolled in MSD-sponsored pembrolizumab trials and are receiving trial treatment or in a Follow-up Phase at the time KN587 is open. The parent trials must have completed all regulatory requirements and submissions, if any, or have fully addressed their primary endpoint(s) before all their participants roll over into KN587.
Informed Consent
2. The participant (or legally acceptable representative if applicable) provides informed consent for the trial and agrees to follow study procedures.

Exclusion Criteria
There are no exclusion criteria to participate in KN587.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Minetta Liu, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Minetta Liu, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Minetta Liu, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20463519

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