Your session is about to expire
← Back to Search
Checkpoint Inhibitor
Pembrolizumab for Advanced Cancers
Phase 3
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequately controlled blood pressure (BP) to <150/90 mmHg, with or without antihypertensive medications
Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 10 years
Awards & highlights
Study Summary
This trial will evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who roll-over into this extension study.
Who is the study for?
This trial is for adults with advanced tumors who were previously in a pembrolizumab study. They must not have had cancer treatment since the last dose of pembrolizumab, be relatively healthy (ECOG status 0 or 1), and women must agree to use contraception. People can't join if they have active brain metastases, certain immune conditions, severe infections like HIV or hepatitis, are pregnant/breastfeeding, or have serious heart/liver/thyroid/diabetes issues.Check my eligibility
What is being tested?
The trial tests long-term safety and effectiveness of pembrolizumab for blood cancers and solid tumors. Participants from earlier studies continue with up to 35 doses every three weeks or up to 17 doses every six weeks. The study has phases depending on prior treatment: First Course Phase, Survival Follow-up Phase, or Second Course Phase.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in organs like lungs (pneumonitis), liver problems, skin reactions, hormone gland issues (like thyroid dysfunction), infusion reactions; also possible are fatigue and allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood pressure is under 150/90 mmHg, with or without medication.
Select...
I am currently on pembrolizumab or lenvatinib treatment.
Select...
I haven't had any cancer treatment since my last pembrolizumab dose.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Duration of Complete Response (DOCR) Per Evaluation Criteria Used in the Parent Study
Duration of Response (DOR) Per Evaluation Criteria Used in the Parent Study
Number of Participants Who Discontinue Study Treatment Due to an AE
+4 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
9Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab 400 mg + SOC (Per Parent Study)Experimental Treatment2 Interventions
Participants receive pembrolizumab 400 mg via IV infusion on Day 1 of each 6-week cycle PLUS SOC treatment (or per parent study if there is no SOC) for up to 17 administrations or more for First Course participants and up to 8 administrations for Second Course participants. Participants receiving a pembrolizumab-based combination treatment will receive the dose regimen of the combination drug(s) which is recommended per SOC or was used in the parent study protocol if there is no SOC recommendation.
Group II: Pembrolizumab 400 mgExperimental Treatment1 Intervention
Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 17 administrations or more for First Course participants and up to 8 administrations for Second Course participants.
Group III: Pembrolizumab 200 mg + SOC: Per Parent Study)Experimental Treatment2 Interventions
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle PLUS standard of care (SOC) treatment (or per parent study if there is no SOC) for up to 35 administrations or more for First Course participants and up to 17 administrations for Second Course participants. Participants receiving a pembrolizumab-based combination treatment will receive the dose regimen of the combination drug(s) which is recommended per SOC or was used in the parent study protocol if there is no SOC recommendation.
Group IV: Pembrolizumab 200 mgExperimental Treatment1 Intervention
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations or more for First Course participants and up to 17 administrations for Second Course participants.
Group V: Lenvatinib 8 mgExperimental Treatment1 Intervention
Participants with body weight (BW)<60 kg receive Lenvatinib 8 mg orally once daily on a 21 or 42 day cycle. It is taken 0-4 hours after completion of pembrolizumabd administration in the clinic on cycle 1 day 1(C1D1), C2D1, C3D1, etc. Taken at home on all other days.
Group VI: Lenvatinib 24 mgExperimental Treatment1 Intervention
Participants with body weight (BW)>60 kg receive Lenvatinib 24 mg orally once daily on a 21 or 42 day cycle. It is taken 0-4 hours after completion of pembrolizumabd administration in the clinic on cycle 1 day 1(C1D1), C2D1, C3D1, etc. Taken at home on all other days.
Group VII: Lenvatinib 20 mgExperimental Treatment1 Intervention
Participants with body weight (BW)>60kg receive Lenvatinib 20mg orally once daily on a 21 or 42 day cycle. It is taken 0-4 hours after completion of pembrolizumabd administration in the clinic on cycle 1 day 1(C1D1), C2D1, C3D1, etc. Taken at home on all other days.
Group VIII: Lenvatinib 12 mgExperimental Treatment1 Intervention
Participants with body weight (BW)>60 kg receive Lenvatinib 12 mg orally once daily on a 21 or 42 day cycle. It is taken 0-4 hours after completion of pembrolizumabd administration in the clinic on cycle 1 day 1(C1D1), C2D1, C3D1, etc. Taken at home on all other days.
Group IX: SOC (Per Parent Study)Active Control1 Intervention
Participants receive the dose matched non-pembrolizumab SOC treatment (e.g. chemotherapy) they were receiving as per parent study protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
2005
Completed Phase 4
~2690
Pembrolizumab
2017
Completed Phase 2
~2010
Standard of Care (SOC)
2017
Completed Phase 4
~2210
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,892 Previous Clinical Trials
5,057,171 Total Patients Enrolled
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,578,635 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,060,244 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer cannot be removed by surgery and has spread.I am eligible for treatment with Lenvatinib.My blood pressure is under 150/90 mmHg, with or without medication.I have lung scarring along with my NSCLC.I am currently being treated for an infection.My liver is not functioning well (Child-Pugh score >6).My thyroid condition is not under control.My diabetes is not under control.I have received a transplant from another person.I have an active tuberculosis infection.I am not participating if I need to start with Lenvatinib.I have not had major surgery in the last 3 weeks.I have recovered from previous cancer treatment side effects, except for hair loss.I do not have conditions that affect drug absorption.I have not coughed up bright red blood (at least 0.5 teaspoon) in the last 3 weeks.I am currently on pembrolizumab or lenvatinib treatment.I haven't had any cancer treatment since my last pembrolizumab dose.I am fully active or restricted in physically strenuous activity but can do light work.My organs are functioning well.I am not pregnant or breastfeeding and agree to use contraception if of childbearing age.I am not pregnant or breastfeeding, and I either can't have children, use effective birth control, or am not having sex.I have an immune system disorder or have been on high-dose steroids or other drugs that weaken my immune system recently.I have another cancer, but it's either early stage or treated and not currently active.I have cancer that has spread to my brain or spinal cord.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have had pneumonitis treated with steroids or have it now.My scans show my tumor is affecting major blood vessels or has hollow areas.I have a severe fistula.My heart's pumping ability is below normal as shown by a heart scan.I have recovered from previous cancer treatment side effects, except for hair loss.I am not pregnant or breastfeeding and agree to use contraception for the required period if of childbearing potential.I have not received a live vaccine in the last 30 days.Currently enrolled in a Merck-sponsored pembrolizumab study, receiving study treatment, and will continue to receive study treatment in the MK-3475-587 extension study if the parent study(ies) are completed.I have or had hepatitis B or C.I do not have severe heart problems like bad arrhythmias, heart failure, or chest pain from poor blood flow.I haven't had serious heart problems in the last year.I agree to avoid unprotected sex or use effective birth control during and 7 days after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Lenvatinib 8 mg
- Group 2: Lenvatinib 20 mg
- Group 3: Lenvatinib 12 mg
- Group 4: Lenvatinib 24 mg
- Group 5: Pembrolizumab 400 mg + SOC (Per Parent Study)
- Group 6: Pembrolizumab 400 mg
- Group 7: Pembrolizumab 200 mg + SOC: Per Parent Study)
- Group 8: SOC (Per Parent Study)
- Group 9: Pembrolizumab 200 mg
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the standard Pembrolizumab treatments?
"Pembrolizumab is a medication used to treat various cancers. It can also be given to patients experiencing disease progression after chemotherapy or those with unresectable melanoma."
Answered by AI
What is the total number of people who are allowed to join this experiment?
"2300 patients that meet the clinical trial's inclusion criteria are required to properly conduct this research. Merck Sharp & Dohme Corp., the sponsor of the study, will be opening sites at Sunnybrook Research Institute ( Site 2802) located in Toronto, Ontario and Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre-Oncology ( Site 2809) situated in Greenfield Park, Quebec."
Answered by AI
What is the precedent for Pembrolizumab's efficacy?
"First studied in 2010, pembrolizumab has had 260 completed clinical trials. As of now, there are 1001 active trials for this medication worldwide with a significant portion taking place in Toronto, Canada."
Answered by AI
Are people who are sick still able to join this experiment?
"Yes, the study is actively recruiting patients. The posting on clinicaltrials.gov says that the trial was first published on 8/21/2018 and updated last on 11/10/2022. They are looking for a total of 2300 participants from 59 different sites."
Answered by AI
Has Pembrolizumab been cleared for use in the United States by the Food and Drug Administration?
"There is existing data that suggests pembrolizumab's efficacy and safety, so our team at Power has given it a score of 3."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 2805)
What portion of applicants met pre-screening criteria?
Met criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger