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Tests treatment safety and results for Solid Tumors
Official title Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)
ClinicalTrials.gov ID: NCT03486873
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumors.
Also referred to as MK-3475, KEYTRUDA®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 transition 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready.
- Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase. Additional eligibility...
- Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Demonstrates adequate organ function.
You likely can't join if
- -There are no exclusion criteria to participate in MK-3475-587. Participants are excluded from entering Second Course trial treatment once they are...
- Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.
- Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or...
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or...
- Has known active central nervous system metastases and/or carcinomatous meningitis.
See the full eligibility criteria
- Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready.
- Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase. Additional eligibility criteria for participants who enter Second Course Phase once they are...
- Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Demonstrates adequate organ function.
- Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is...
- A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the...
- Adequately controlled blood pressure (BP) to \<150/90 mmHg, with or without antihypertensive medications.
- For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib.
- Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective...
- -There are no exclusion criteria to participate in MK-3475-587. Participants are excluded from entering Second Course trial treatment once they are enrolled on MK-3475-587 if any of the following criteria applies:
- Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.
- Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment.
- 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...
- 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...
- Has known active central nervous system metastases and/or carcinomatous meningitis.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine...
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent...
- Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease.
- Has an active infection requiring systemic therapy.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for...
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study...
- Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease.
- Has hepatic decompensation (Child-Pugh score \>6 [class B and C]).
- Has uncontrolled thyroid dysfunction.
- Has uncontrolled diabetes mellitus.
- Has had an allogeneic tissue/solid organ transplant.
- Has a known history of active tuberculosis (TB; Bacillus tuberculosis). Additional exclusion criteria for participants who enter dosing with Lenvatinib:
- Has had major surgery within 3 weeks prior to first dose of study intervention(s).
- Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.
- Has urine protein ≥1 g/24 hours.
- Has LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).
- Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.
- Prolongation of QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval to \>480 ms.
- Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial...
- Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.
- Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.
- Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib.
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Bakersfield, California, United States
- Fresno, California, United States
- Fullerton, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- San Francisco, California, United States
- Santa Monica, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Fort Lauderdale, Florida, United States
- Jacksonville, Florida, United States
- Miami Beach, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Augusta, Georgia, United States
- Marietta, Georgia, United States
- Honolulu, Hawaii, United States
+ 526 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Bakersfield, California, United States; Fresno, California, United States; Fullerton, California, United States; Los Angeles, California, United States; Orange, California, United States and 540 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.