Trial Outcomes & Findings for Umbralisib and Pembrolizumab in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (NCT NCT03776864)

Last Updated: 2023-05-03

Results Overview

Proportion of subjects with relapsed/ refractory classical Hodgkin Lymphoma (CHL) who achieve a complete response (CR) with a regimen of umbralisib (oral, daily) and pembrolizumab (IV, day 1 of 21-day cycles). Per Response Evaluation Criteria Lugano 2014 for target lesions and assessed by PET-CT, Complete Metabolic Response (CMR), Deaville score of 1, 2, or 3 in nodal or extranodal sites with or without residual mass.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Up to 1 year

Results posted on

2023-05-03

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Pembrolizumab, Umbralisib) Patients receive pembrolizumab IV on day 1. Treatment repeats every 21 for up to 16 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive umbralisib PO daily on days 1-21 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given IV Umbralisib: Given PO
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Umbralisib and Pembrolizumab in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Pembrolizumab, Umbralisib) n=6 Participants Patients receive pembrolizumab IV on day 1. Treatment repeats every 21 for up to 16 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive umbralisib PO daily on days 1-21 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given IV Umbralisib: Given PO
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=99 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants
Age, Continuous	46 years n=99 Participants
Sex: Female, Male Female	2 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Sex: Female, Male Male	4 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) White	5 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	6 Participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Outcome measures

Outcome measures
Measure	Treatment (Pembrolizumab, Umbralisib) n=6 Participants Patients receive pembrolizumab IV on day 1. Treatment repeats every 21 for up to 16 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive umbralisib PO daily on days 1-21 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given IV Umbralisib: Given PO
Complete Response Rate	0 Participants

SECONDARY outcome

Timeframe: Up to 1 year

Proportion of subjects with relapsed/ refractory classical Hodgkin Lymphoma (CHL) who achieve an overall response (OR) with a regimen of umbralisib (oral, daily) and pembrolizumab (IV, day 1 of 21-day cycles). Per Response Evaluation Criteria Lugano 2014 for target lesions and assessed by PET-CT, Complete Metabolic Response (CMR), Deaville score of 1, 2, or 3 in nodal or extranodal sites with or without residual mass; Partial Metabolic Response, Deauville score of 4 or 5 with reduced uptake compared to baseline and residual mass(es) of any size; No Response or Stable Disease, Deauville score of 4 or 5 with no significant change in FDG uptake from baseline at interim or end of treatment.

Outcome measures

Outcome measures
Measure	Treatment (Pembrolizumab, Umbralisib) n=6 Participants Patients receive pembrolizumab IV on day 1. Treatment repeats every 21 for up to 16 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive umbralisib PO daily on days 1-21 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given IV Umbralisib: Given PO
Overall Response Rate	3 Participants

SECONDARY outcome

Timeframe: Up to 28 days post-treatment, approximately 2 years

Measured via CTCAE v4.0. Incidence of adverse events is defined as the count of participants who experienced an adverse event.

Outcome measures

Outcome measures
Measure	Treatment (Pembrolizumab, Umbralisib) n=6 Participants Patients receive pembrolizumab IV on day 1. Treatment repeats every 21 for up to 16 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive umbralisib PO daily on days 1-21 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given IV Umbralisib: Given PO
Number of Participants With Adverse Events	6 Participants

Adverse Events

Treatment (Pembrolizumab, Umbralisib)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Pembrolizumab, Umbralisib) n=6 participants at risk Patients receive pembrolizumab IV on day 1. Treatment repeats every 21 for up to 16 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive umbralisib PO daily on days 1-21 days. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Pembrolizumab: Given IV Umbralisib: Given PO
Gastrointestinal disorders Abdominal Pain	33.3% 2/6 • Number of events 3 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Investigations Alanine aminotransferase increased	50.0% 3/6 • Number of events 7 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Metabolism and nutrition disorders Anorexia	16.7% 1/6 • Number of events 1 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Psychiatric disorders Anxiety	16.7% 1/6 • Number of events 2 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Investigations Aspartate aminotransferase increased	50.0% 3/6 • Number of events 5 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Investigations Blood bilirubin increased	16.7% 1/6 • Number of events 1 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Gastrointestinal disorders Constipation	16.7% 1/6 • Number of events 1 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Respiratory, thoracic and mediastinal disorders Cough	50.0% 3/6 • Number of events 3 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Psychiatric disorders Depression	16.7% 1/6 • Number of events 1 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Gastrointestinal disorders Diarrhea	50.0% 3/6 • Number of events 5 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
General disorders Fatigue	16.7% 1/6 • Number of events 1 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
General disorders Fever	16.7% 1/6 • Number of events 2 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Nervous system disorders Headache	33.3% 2/6 • Number of events 2 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Musculoskeletal and connective tissue disorders Neck Pain	33.3% 2/6 • Number of events 2 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Nervous system disorders Lightheadedness	16.7% 1/6 • Number of events 1 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Gastrointestinal disorders Nausea	16.7% 1/6 • Number of events 2 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Gastrointestinal disorders Vomiting	33.3% 2/6 • Number of events 2 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Skin and subcutaneous tissue disorders Rash	16.7% 1/6 • Number of events 2 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Vascular disorders Hot flashes	16.7% 1/6 • Number of events 1 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Renal and urinary disorders Frequent urination	16.7% 1/6 • Number of events 1 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Renal and urinary disorders Difficulty urinating	16.7% 1/6 • Number of events 1 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Musculoskeletal and connective tissue disorders Pain in extremities	16.7% 1/6 • Number of events 2 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Nervous system disorders Peripheral neuropathy	16.7% 1/6 • Number of events 1 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
General disorders Palate lesion	16.7% 1/6 • Number of events 1 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
General disorders Allergies	16.7% 1/6 • Number of events 1 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Psychiatric disorders Insomnia	16.7% 1/6 • Number of events 1 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
General disorders Bilateral axilla pain	16.7% 1/6 • Number of events 1 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Injury, poisoning and procedural complications Infusion related reaction	16.7% 1/6 • Number of events 1 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
General disorders Chest pain	16.7% 1/6 • Number of events 1 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Musculoskeletal and connective tissue disorders Cramping in legs	16.7% 1/6 • Number of events 1 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Gastrointestinal disorders Bitter taste in mouth	16.7% 1/6 • Number of events 1 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Musculoskeletal and connective tissue disorders Lower back pain	16.7% 1/6 • Number of events 1 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Musculoskeletal and connective tissue disorders Soreness	16.7% 1/6 • Number of events 1 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.
Vascular disorders Perceived distal vascular insufficiency	16.7% 1/6 • Number of events 1 • Adverse were collected from the time of informed consent through 28 days after last dose of study drug. Adverse events were collected for 2 years.

Additional Information

Dr. Ryan Lynch

University of Washington

Phone: 206-606-1739

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place