A Multicenter, Open label, Phase III Extension Trial to Study the Long-term Safety and Efficacy in Participants with Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab Trial.
- Conditions
- advanced tumorcancer100386661002910710040900
- Registration Number
- NL-OMON52613
- Lead Sponsor
- Merck Sharp & Dohme (MSD)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 18
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. Participants must be from MSD-sponsored
pembrolizumab parent trials established by the Sponsor as KN-587 transition
ready.
2. The participant (or legally acceptable representative if applicable)
provides informed consent for the trial and agrees to follow study
procedures.
There are no exclusion criteria to participate in KN587., Participants are
excluded from entering Second Course trial treatment once they are enrolled on
KN587 if any of the following criteria applies:
1. Woman of Childbearing Potential who has a positive urine pregnancy test
within 72 hours prior to trial treatment allocation. If the urine test is
positive or cannot be confirmed as negative, a serum pregnancy test will be
required.
2. Has severe hypersensitivity (>= Grade 3) to pembrolizumab and/or any of its
excipients (the list of excipients is provided in the IB).
3. Has received a live vaccine within 30 days prior to the first dose of Second
Course Phase trial treatment. Examples of live vaccines include, but are not
limited to, the following: measles, mumps, rubella, varicella/zoster (chicken
pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine.
Seasonal influenza vaccines for injection are generally killed virus vaccines
and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live
attenuated vaccines and are not allowed.
4. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid
therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other
form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of
Second Course Phase.
5. Has a known additional malignancy that is progressing or requires active
treatment. Exceptions include early stage cancers (carcinoma in situ or Stage
1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal
cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ
cervical cancer, or in situ breast cancer that has undergone potentially
curative therapy.
6. Has known active central nervous system metastases and/or carcinomatous
meningitis.
7. Has an active autoimmune disease that has required systemic treatment in the
past 2 years (ie. use of disease modifying agents, corticosteroids or
immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or
physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency) is not considered a form of systemic treatment and is allowed.
8. Has a history of (non-infectious) pneumonitis that required steroids or has
current pneumonitis.
9. NSCLC participants only: Has interstitial lung disease.
10. Has an active infection requiring systemic therapy.
11. Has a known history of human immunodeficiency virus infection.
12. Has a known history of or is positive for hepatitis B (hepatitis B surface
antigen reactive) or hepatitis C (hepatitis C virus RNA [qualitative] is
detected). Hepatitis C lab testing is allowed for eligibility purposes in
countries where hepatitis C virus RNA is not part of SOC.
13. Is pregnant or breastfeeding or expecting to conceive or father children
within the projected duration of the trial, starting with the Second Course
Phase eligibility Visit through 120 days after the last dose of trial treatment.
14. Has severe cardiovascular disease, ie. arrhythmias, requiring chronic
treatment, congestive heart failure (New York Heart Association Class III or
IV) or symptomatic ischemic heart disease.
15. Has hepatic decompensation (Child-Pugh score > 6 [class B and C]).
16. Has uncontrolled thyroid dysfunction.
17.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To estimate the overall survival (OS)</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. To estimate the Duration of Response (DOR) and Duration of Complete Response<br /><br>(DOCR) per evaluation criteria used in the parent trial by investigator<br /><br>assessment for participants who have received or are receiving First Course<br /><br>Phase trial treatment with pembrolizumab or a pembrolizumab-based combination.<br /><br>2. To evaluate the safety and tolerability of pembrolizumab or a<br /><br>pembrolizumab-based combination in subjects who receive it as First or Second<br /><br>Course Phase trial treatment.</p><br>