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Monoclonal Antibodies

Pembrolizumab for Lymphoma

Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 31 months
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a new drug, MK-2118, for treating advanced solid tumors or lymphomas. The drug will be given by injection, either alone or in combination with another drug, pembrolizumab.

Eligible Conditions
  • Lymphoma
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 31 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 31 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events (AEs)
Mutagenicity Tests
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Secondary outcome measures
MK-2118 Area Under the Concentration-time Curve from 0 to 24 hours (AUC 0-24hr)
MK-2118 Maximum Plasma Concentration (Cmax)
MK-2118 Minimum Plasma Concentration (Cmin)
+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
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

4Treatment groups
Experimental Treatment
Group I: Arm 4: MK-2118 SC+Pembro Combo TherapyExperimental Treatment2 Interventions
Participants receive MK-2118 monotherapy via subcutaneous (SC) injection Q1W on Cycle 1 Days 1 and 8 followed by MK-2118 SC injection Q1W on Cycles 2-4 Days 1, 8 and 15, for a total of up to 36 cycles (approximately 2 years) plus pembrolizumab 200 mg via IV infusion on Day 1 of Cycle 2 and beyond for up to 36 cycles (approximately 2 years). Cycle 1 is 2 weeks long and Cycles 2 and beyond are 3 weeks long.
Group II: Arm 3: MK-2118 Visceral IT+Pembro Combo TherapyExperimental Treatment2 Interventions
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle for up to 35 cycles (approximately 2 years) and receive MK-2118 via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-2 followed by MK-2118 IT injection Q3W on Day 1 of Cycle 3 and beyond, for a total of up to 35 cycles (approximately 2 years). Each cycle is 3 weeks long.
Group III: Arm 2: MK-2118 IT+Pembro Combo TherapyExperimental Treatment2 Interventions
Participants receive pembrolizumab (pembro) 200 mg via IV infusion on Day 1 of each cycle for up to 35 cycles (approximately 2 years) and receive MK-2118 via IT injection Q1W on Days 1, 8 and 15 of Cycles 1-3 followed by MK-2118 IT injection Q3W on Day 1 of Cycle 4 and beyond, for a total of up to 35 cycles (approximately 2 years). Each cycle is 3 weeks long.
Group IV: Arm 1: MK-2118 IT MonotherapyExperimental Treatment1 Intervention
Participants receive MK-2118 via IT injection once weekly (Q1W) on Days 1, 8 and 15 of Cycles 1-3 followed by MK-2118 via IT injection once every 3 weeks (Q3W) on Day 1 of Cycle 4 and beyond, for a total of up to 35 cycles (approximately 2 years). Each cycle is 3 weeks long.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-2118 (SC)
2017
Completed Phase 1
~140
Pembrolizumab
2017
Completed Phase 2
~2010
MK-2118 (IT)
2017
Completed Phase 1
~140

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,995 Total Patients Enrolled
27 Trials studying Lymphoma
2,841 Patients Enrolled for Lymphoma
Merck Sharp & Dohme LLCLead Sponsor
3,888 Previous Clinical Trials
5,059,795 Total Patients Enrolled
91 Trials studying Lymphoma
8,465 Patients Enrolled for Lymphoma
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,600 Total Patients Enrolled
40 Trials studying Lymphoma
11,500 Patients Enrolled for Lymphoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many venues are implementing this clinical experiment?

"Currently, 5 clinical trial sites are registering participants for the study. These locations can be found in Pittsburgh, Chicago and Dallas as well a few other places. In order to reduce travel needs, it is advised that you select the nearest clinic available."

Answered by AI

Has the Food and Drug Administration granted approval for Pembrolizumab?

"Limited evidence is available for Pembrolizumab's safety and efficacy, so it was assigned a score of 1."

Answered by AI

Are there any vacancies remaining in this clinical trial?

"This trial is now closed; it had been published on September 20th 2017, and updated for the last time on November 17th 2022. However, those seeking additional studies can find 2136 open clinical trials for lymphoma patients and 963 trials recruiting participants to test Pembrolizumab."

Answered by AI

What is the current capacity for enrollment in this trial?

"At the time of writing, this trial is not taking on any more candidates. The posting was first made in September 2017 with a final update occurring in November 2022. Those looking for other studies may be interested to know that there are 2136 medical trials involving lymphoma and 963 concerning Pembrolizumab actively accepting enrolment applications."

Answered by AI

In what circumstances is the drug Pembrolizumab typically utilized?

"Pembrolizumab is approved for treating malignant neoplasms and conditions like unresectable melanoma, microsatellite instability high, or chemotherapy-induced progression."

Answered by AI

What precedent has been set for Pembrolizumab in the past?

"At the present moment, there are 963 active clinical trials being conducted regarding pembrolizumab. Out of those studies, 122 have achieved Phase 3 status. Although Houston is a primary research hub for this medication, 35772 locations worldwide are running investigations on its efficacy."

Answered by AI

What are the major aims of this research endeavor?

"The primary goal of this clinical trial, evaluated over a period spanning 21-35 days depending on the arm, will be to determine the Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE). Secondary objectives include analyzing MK2118's Maximum Plasma Concentration (Cmax), Pembrolizumab Cmin and MK-2118 Minimum Plasma Concentration (Cmin) which are all assessed during various predefined time points."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of MK-2118 Administered as Intratumoral Injection as Monotherapy and in Combination With Pembrolizumab (MK-3475) or by Subcutaneous Injection in Combination With Pembrolizumab in the Treatment of Adults With Advanced/Metastatic Solid Tumors or Lymphomas (MK-2118-001)
2017. "Study of MK-2118 Administered as Intratumoral Injection as Monotherapy and in Combination With Pembrolizumab (MK-3475) or by Subcutaneous Injection in Combination With Pembrolizumab in the Treatment of Adults With Advanced/Metastatic Solid Tumors or Lymphomas (MK-2118-001)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03249792.
~18 spots leftby Apr 2025
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