Pembrolizumab for Hodgkin Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Ankara University Hospital Cebeci-hematology ( Site 5000), Ankara, Turkey
Hodgkin Disease+2 More
Pembrolizumab - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new drug called pembrolizumab can be used to treat cancer.

See full description

Eligible Conditions

  • Hodgkin Disease
  • Classical Hodgkin's Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Hodgkin Disease

Study Objectives

This trial is evaluating whether Pembrolizumab will improve 1 primary outcome and 6 secondary outcomes in patients with Hodgkin Disease. Measurement will happen over the course of Up to approximately 9 weeks.

Week 17
PET Negativity by Independent Central Review Per FDG-PET 5-point Scale After Administration of Pembrolizumab Monotherapy and Chemotherapy
Week 57
CR at the End of Study Intervention as Assessed by Investigator Per Lugano 2014 Response Criteria
Complete Response (CR) at the End of Study Intervention as Assessed by Independent Central Review (ICR) Per Lugano 2014 Response Criteria
Number of Participants Who Discontinued Study Treatment Due to an AE
Week 64
Number of Participants Who Experienced an Adverse Event (AE)
Month 72
Duration of Complete Response (DurCR) as Assessed by Independent Central Review Per Lugano 2014 Response Criteria
Week 9
Positron Emission Tomography (PET) Negativity by Independent Central Review Per 3-Fluorodeoxyglucose (FDG)-PET 5-point Scale After Administration of Pembrolizumab Monotherapy

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Hodgkin Disease

Trial Design

1 Treatment Group

Pembrolizumab Monotherapy + Chemotherapy + Pembrolizumab Consolidation
1 of 1
Experimental Treatment

This trial requires 140 total participants across 1 different treatment group

This trial involves a single treatment. Pembrolizumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Pembrolizumab Monotherapy + Chemotherapy + Pembrolizumab ConsolidationParticipants 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
Procarbazine
FDA approved
Pembrolizumab
FDA approved
Vinblastine
FDA approved
Bleomycin
FDA approved
Dacarbazine
FDA approved
Doxorubicin
FDA approved
Cyclophosphamide
FDA approved
Vincristine
FDA approved
Etoposide
FDA approved
Prednisone
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 72 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to approximately 72 months for reporting.

Closest Location

University of Tennessee Medical Center-Cancer Institute ( Site 0006) - Knoxville, TN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Hodgkin Disease or one of the other 2 conditions listed above. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The text states that the disease is measurable and FDG-avid according to Lugano 2014 response criteria. show original
This patient has not received radiation therapy, chemotherapy, immunotherapy, or any other systemic therapy before the first dose of study intervention. show original
The patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days before the start of study intervention. show original
The person has to have a confirmed diagnosis of Ann Arbor Stage III or IV classical Hodgkin Lymphoma to participate show original

Patient Q&A Section

How many people get lymphoma a year in the United States?

"The incidence of NHL is increasing; however, the rates remain stable among all demographic groups. Data from a recent study suggest that increased awareness and early detection may contribute to the rise in NHL incidence." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets lymphoma?

"The median age of diagnosis of HL is 68 years (mean 61.3), with a range of 28 to 90 years. Median age at death from HL is 72 years (mean 70.7) with a range of 30 to 94 years. There were no significant differences in age at diagnosis or death between males and females." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in pembrolizumab for therapeutic use?

"Based on these results, we believe that pembrolizumab has a role in the treatment of refractory or recurrent HL. However, further phase III studies will need to address optimal dosing schedules and mechanisms of resistance." - Anonymous Online Contributor

Unverified Answer

Does lymphoma run in families?

"Although one family history of lymphoma has been reported, its presence is not indicative of familial inheritance of lymphoma. No evidence was found that any of the families had a hereditary predisposition to lymphoma, nor was a significant difference seen in the age at onset between families with a positive family history and those without a family history (P > 0.05)." - Anonymous Online Contributor

Unverified Answer

What is pembrolizumab?

"Pembrolizumab is a monoclonal antibody specific for the PD-1 receptor. In clinical trials, it has demonstrated antitumor efficacy against multiple cancer types including non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), squamous cell carcinoma of head and neck (SCCHN), and Merkel-cell carcinoma. It is approved by the FDA for treatment of patients with metastatic melanoma who have failed previous treatments and are not candidates for surgery or radiotherapy." - Anonymous Online Contributor

Unverified Answer

How does pembrolizumab work?

"Pembrolizumab is safe and effective in the treatment of patients with advanced NHL. Patients treated with pembrolizumab had a significant improvement in their symptoms and duration of remission when compared with patients treated with rituximab or CHOP alone. The median time to disease progression was 8.3 months in patients treated with pembrolizumab versus 6.4 months in patients treated with CHOP alone. Survival data are awaited. Clinicaltrials.gov ID: NCT00557145." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving pembrolizumab?

"Pembrolizumab appears effective in the treatment of patients with advanced solid tumors. Although our results are encouraging, larger, prospective studies are needed to confirm these findings." - Anonymous Online Contributor

Unverified Answer

How quickly does lymphoma spread?

"Although the results showed that there is no correlation between pathological findings and clinical manifestations in patients with localized diffuse large B-cell lymphoma, we recommend fixation of specimens and sending them to labs for immunohistochemical studies to investigate whether a relationship exists between histological features and clinical presentation." - Anonymous Online Contributor

Unverified Answer

What does pembrolizumab usually treat?

"In this review, only one randomized controlled trial had been published (without blinding). It seems likely that most patients who receive pembrolizumab will be unable to generate meaningful data because they will not know if they received the drug or placebo. Overall, there is little evidence of benefit from pembrolizumab and no evidence of harm. Although more data on long term efficacy is needed, current information suggests that pembrolizumab may be useful in treating relapsed or refractory disease. Patients should be informed that although pembrolizumab has shown promise in a few rare cases, they are unlikely to experience a durable response to treatment with this agent." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for lymphoma?

"Survival rates for most types of lymphoma are very high; however, with some types of lymphoma such as mantle cell lymphoma and diffuse large B-cell lymphoma, those diagnosed with stage IV disease have poor outcomes. These patients usually receive standard chemotherapy regimens that do not appear to improve their overall survival compared with patients treated with observation alone. Patients with early or advanced stage Hodgkin's lymphoma have better outcomes. There may be additional benefits of chemotherapy in treating Hodgkin's lymphoma but further research needs to be conducted to determine these outcomes." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of pembrolizumab?

"The most common adverse reactions in patients treated with pembrolizumab were fatigue, fever, nausea, rash, and itchiness. There were no serious adverse events reported in patients treated with pembrolizumab. An increase in liver enzymes and hyperglycemia were also observed, although they did not appear to be clinically significant. Patients treated with pembrolizumab should be closely monitored during treatment and throughout their follow-up period for symptoms associated with increased risk of infection and autoimmune disorders. Pembrolizumab does not appear to have negative effects on fertility. A child born to a woman who received pembrolizumab while pregnant has been reported." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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