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Anti-tumor antibiotic

Pembrolizumab + Chemotherapy for Hodgkin's Lymphoma (KEYNOTE-C11 Trial)

Phase 2
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
Has not received prior radiation therapy, chemotherapy, immunotherapy, or other systemic therapy for the treatment of cHL before the first dose of study intervention
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 72 months
Awards & highlights

KEYNOTE-C11 Trial Summary

This trial will test whether pembrolizumab, a cancer immunotherapy drug, is more effective than chemotherapy at treating non-small cell lung cancer.

Who is the study for?
This trial is for individuals with newly diagnosed classical Hodgkin Lymphoma (cHL), specifically those who haven't had prior treatments and have a confirmed diagnosis of Ann Arbor Stage III or IV cHL. Participants can also be in earlier stages if they have certain risk factors. They should be relatively healthy, with an ECOG Performance Status of 0 to 1.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of pembrolizumab alone, followed by chemotherapy, then more pembrolizumab as consolidation therapy. It aims to see if this approach leads to higher complete response rates compared to conventional chemotherapy for cHL.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects like inflammation in various organs, skin reactions, hormone gland problems (like thyroid issues), and infusion-related reactions. Chemotherapy drugs can lead to nausea, hair loss, fatigue, increased infection risk due to low blood cell counts.

KEYNOTE-C11 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I haven't had any treatment for classical Hodgkin lymphoma before this study.

KEYNOTE-C11 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 72 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 72 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
Complete Response (CR) at the End of Study Intervention as Assessed by Independent Central Review (ICR) Per Lugano 2014 Response Criteria
Secondary outcome measures
CR at the End of Study Intervention as Assessed by Investigator Per Lugano 2014 Response Criteria
Duration of Complete Response (DurCR) as Assessed by Independent Central Review Per Lugano 2014 Response Criteria
Number of Participants Who Discontinued Study Treatment Due to an AE
+3 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%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

KEYNOTE-C11 Trial Design

1Treatment groups
Experimental Treatment
Group I: Pembrolizumab Monotherapy + Chemotherapy + Pembrolizumab ConsolidationExperimental Treatment10 Interventions
Participants receive pembrolizumab monotherapy followed by chemotherapy with doxorubicin in combination with vinblastine & dacarbazine (AVD) or chemotherapy with escalated bleomycin in combination with etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, & prednisone (escBEACOPP) followed by pembrolizumab consolidation. All participants receive pembrolizumab monotherapy intravenous (IV) for 3 cycles (cycle length = 3 weeks (wks); up to 9 wks). All participants receive AVD IV for 2 cycles (cycle length = 4 wks; up to 8 wks) after Positron Emission Tomography (PET) 2. Participants who are PET 3 -ve, or +ve & age ≥ 60 years, receive up to 4 additional cycles of AVD IV (cycle length = 4 wks, up to 16 wks), or up to 4 cycles of escBEACOPP IV if PET 3 +ve, age <60 years; cycle length = 3 wks; up to 12 wks. All participants receive pembrolizumab consolidation IV for 4 cycles (cycle length = 6 wks; up to 24 wks). Total treatment duration is up to 57 wks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950
Doxorubicin
2012
Completed Phase 3
~7940
Vinblastine
1998
Completed Phase 3
~5260
Dacarbazine
2005
Completed Phase 3
~5110
Bleomycin
2001
Completed Phase 3
~4960
Etoposide
2010
Completed Phase 3
~2440
Cyclophosphamide
1995
Completed Phase 3
~3780
Vincristine
2003
Completed Phase 4
~2920
Procarbazine
1998
Completed Phase 3
~2170
Prednisone
2014
Completed Phase 4
~2370

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,765 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,862 Previous Clinical Trials
5,049,554 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,769 Previous Clinical Trials
8,062,054 Total Patients Enrolled

Media Library

Bleomycin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05008224 — Phase 2
Hodgkin's Lymphoma Research Study Groups: Pembrolizumab Monotherapy + Chemotherapy + Pembrolizumab Consolidation
Hodgkin's Lymphoma Clinical Trial 2023: Bleomycin Highlights & Side Effects. Trial Name: NCT05008224 — Phase 2
Bleomycin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05008224 — Phase 2

Frequently Asked Questions

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

Is Pembrolizumab a safe and effective treatment for individuals?

"Given that Pembrolizumab is currently in Phase 2, the safety of this drug was estimated as a 2 on Power's scale. This implies that there are some results indicating safety but no evidence for efficacy yet."

Answered by AI

How many healthcare facilities are participating in the research of this trial?

"Currently, 11 medical centres are enrolling participants for this clinical trial. These locations include Las Vegas, Fullerton and Edmonton in addition to 8 other cities. It is recommended that those interested select the nearest site available so as to reduce travel obligations."

Answered by AI

Are there any vacancies in the research protocol that participants can join?

"The records available on clinicaltrials.gov suggest that this trial is now closed for recruitment, having first been posted on October 7th 2021 and last updated July 12th 2022. Nevertheless, there are still 3970 other trials recruiting patients at the moment."

Answered by AI

Is this trial a pioneering effort in its field?

"To date, 2246 studies with Pembrolizumab have been conducted in 79 countries and 3969 cities. The inaugural trial of this medication occurred back in 1997, sponsored by Alfacell; it enrolled 300 participants and achieved Phase 3 approval status. Since then, 2389 trials involving the drug have concluded."

Answered by AI

How is Pembrolizumab typically employed in medical treatments?

"As a common treatment for advanced testicular cancer, pembrolizumab has also been used to alleviate symptoms of conditions such as ulcerative colitis and varicella-zoster virus acute retinal necrosis. Additionally, the drug can be utilized in treating pheochromocytomas."

Answered by AI

Are there precedents of Pembrolizumab being used in medical research?

"Pembrolizumab was initially explored in 1997 at Butterworth Campus of Spectrum Health Hospital. Now, 2389 trials have been concluded and 2246 are actively being conducted - with a significant number occurring in Las Vegas, Nevada."

Answered by AI

How many participants are enrolled in this clinical experiment?

"Unfortunately, no new patients are being accepted for this trial at the present moment. The study was first published on October 7th 2021 and has been edited most recently on July 12th 2022. In case you're searching for other research endeavours, there currently exist 1724 studies actively looking for participants with Hodgkin Disease along with 2246 studies in search of Pembrolizumab candidates."

Answered by AI
~43 spots leftby Mar 2025