Pembrolizumab for Refractory Hodgkin Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Refractory Hodgkin Lymphoma+1 MorePembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study if CAR-T cells can be used to treat cHL, and if they can be combined with PD-1 antibodies to improve clinical responses.

Eligible Conditions
  • Refractory Hodgkin Lymphoma
  • Relapsed Hodgkin's Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: From first day of anti-PD-1 therapy to clinical progression or death, up to 15 years

12 weeks
Objective response, defined as complete response (CR) or partial response (PR) at 12 weeks after initiating anti-PD-1 therapy
42 days
T-Lymphocyte Subsets
Peripheral T-cell receptor frequency per 100,000 clones on Day 1, Day 21, and Day 42 of anti-PD-1 therapy.
Year 15
Progression free survival

Trial Safety

Side Effects for

Pembrolizumab+EP
54%Neutropenia
45%Anaemia
38%Nausea
34%Alopecia
31%Decreased appetite
29%Constipation
27%Fatigue
26%Thrombocytopenia
22%Leukopenia
21%Diarrhoea
20%Cough
17%Asthenia
17%Dyspnoea
16%Vomiting
14%Pyrexia
14%Dizziness
13%Arthralgia
13%Rash
13%Headache
12%Hypothyroidism
11%Insomnia
11%Pruritus
11%Back pain
10%Weight decreased
9%Hyponatraemia
9%Aspartate aminotransferase increased
8%Oedema peripheral
8%Upper respiratory tract infection
8%Alanine aminotransferase increased
8%Pneumonia
7%Abdominal pain
7%Blood creatinine increased
7%Hypokalaemia
7%Febrile neutropenia
6%Abdominal pain upper
6%Stomatitis
6%Dysgeusia
6%Erythema
6%Dry skin
5%Hyperthyroidism
5%Dyspepsia
5%Dysphagia
5%Chest pain
5%Blood alkaline phosphatase increased
5%Musculoskeletal pain
5%Hypertension
5%Nasopharyngitis
5%Musculoskeletal chest pain
5%Pain in extremity
4%Urinary tract infection
4%Hypotension
2%Death
2%Acute kidney injury
2%Pneumonitis
2%Pulmonary embolism
2%Atrial fibrillation
1%Neutropenic sepsis
1%Inappropriate antidiuretic hormone secretion
1%Diabetes mellitus
1%Hemiparesis
1%Transient ischaemic attack
1%Superior vena cava syndrome
1%Pneumothorax
1%Gastritis
1%Aortic aneurysm
1%Sepsis
1%Pleural infection
1%Infusion related reaction
1%Clostridium difficile colitis
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab+EP ARM group. Side effects include: Neutropenia with 54%, Anaemia with 45%, Nausea with 38%, Alopecia with 34%, Decreased appetite with 31%.

Trial Design

3 Treatment Groups

Single Arm PD-1 Inhibitors after CD30.CAR-T Therapy
1 of 3
Arm 1: Relapse After Prior CD30 CAR-T Therapy
1 of 3
Arm 2: Relapse with no Prior CD30 CAR-T Therapy
1 of 3

Experimental Treatment

20 Total Participants · 3 Treatment Groups

Primary Treatment: Pembrolizumab · No Placebo Group · Phase < 1

Single Arm PD-1 Inhibitors after CD30.CAR-T TherapyExperimental Group · 2 Interventions: Nivolumab, Pembrolizumab · Intervention Types: Biological, Biological
Arm 1: Relapse After Prior CD30 CAR-T TherapyExperimental Group · 2 Interventions: Nivolumab, Pembrolizumab · Intervention Types: Biological, Biological
Arm 2: Relapse with no Prior CD30 CAR-T TherapyExperimental Group · 2 Interventions: Nivolumab, Pembrolizumab · Intervention Types: Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from first day of anti-pd-1 therapy to clinical progression or death, up to 15 years

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
311 Previous Clinical Trials
81,788 Total Patients Enrolled
American Society of Clinical OncologyOTHER
27 Previous Clinical Trials
146,799 Total Patients Enrolled
Timothy Voorhees, MDPrincipal InvestigatorClinical Fellow
Natalie Grover, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center
7 Previous Clinical Trials
237 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Relapse after prior CD30 CAR-T therapy.
You have relapsed with no prior CD30 CAR-T therapy.
You have relapsed/refractory classical Hodgkin lymphoma after at least three lines of prior therapy with clinical progression after either ATLCAR.CD30 and/or ATLCAR.CD30.CCR4.
Subjects with prior allogeneic stem cell transplant will be eligible but will be counseled during consent regarding possible increased risk of graft versus host disease with anti-PD-1 therapy after allogeneic stem cell transplant.