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NCT03776864

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

Terminated Phase 2 Results posted Last updated 3 May 2023
What this trial tests

Phase 2 trial testing Pembrolizumab in Hodgkin's Lymphoma in 6 participants. Terminated before completion.

Timeline
26 September 2019
Primary endpoint
14 September 2021
14 September 2021

Quick facts

Lead sponsorUniversity of Washington
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment6
Start date26 September 2019
Primary completion14 September 2021
Estimated completion14 September 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Washington

Who can join

18 and older, any sex, with Hodgkin's Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Complete Response Rate Primary · Up to 1 year

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.

GroupValue95% CI
Treatment (Pembrolizumab, Umbralisib)0
Overall Response Rate Secondary · 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 o

GroupValue95% CI
Treatment (Pembrolizumab, Umbralisib)3
Number of Participants With Adverse Events Secondary · 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.

GroupValue95% CI
Treatment (Pembrolizumab, Umbralisib)6

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Pembrolizumab, Umbralisib)
Serious: 0/6 (0%)
Deaths: 0/6
Other adverse events (34 terms — click to expand)

ReactionSystemTreatment (Pembrolizumab, …
Alanine aminotransferase increasedInvestigations
Aspartate aminotransferase increasedInvestigations
CoughRespiratory, thoracic and mediastinal disorders
DiarrheaGastrointestinal disorders
Abdominal PainGastrointestinal disorders
HeadacheNervous system disorders
Neck PainMusculoskeletal and connective tissue disorders
VomitingGastrointestinal disorders
AnorexiaMetabolism and nutrition disorders
AnxietyPsychiatric disorders
Blood bilirubin increasedInvestigations
ConstipationGastrointestinal disorders
DepressionPsychiatric disorders
FatigueGeneral disorders
FeverGeneral disorders
LightheadednessNervous system disorders
NauseaGastrointestinal disorders
RashSkin and subcutaneous tissue disorders
Hot flashesVascular disorders
Frequent urinationRenal and urinary disorders
Difficulty urinatingRenal and urinary disorders
Pain in extremitiesMusculoskeletal and connective tissue disorders
Peripheral neuropathyNervous system disorders
Palate lesionGeneral disorders
AllergiesGeneral disorders
InsomniaPsychiatric disorders
Bilateral axilla painGeneral disorders
Infusion related reactionInjury, poisoning and procedural complications
Chest painGeneral disorders
Cramping in legsMusculoskeletal and connective tissue disorders
Bitter taste in mouthGastrointestinal disorders
Lower back painMusculoskeletal and connective tissue disorders
SorenessMusculoskeletal and connective tissue disorders
Perceived distal vascular insufficiencyVascular disorders

Data from ClinicalTrials.gov NCT03776864 adverse events section.

Sponsor's own description

This phase II trial studies how well umbralisib and pembrolizumab work in treating patients with classical Hodgkin lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Umbralisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Giving umbralisib and pembrolizumab may work better in treating classical Hodgkin lymphoma.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Wnt/β-catenin signaling in cancers and targeted therapies.
    Yu F, Yu C, Li F, Zuo Y, et al · · 2021 · cited 565× · PMID 34456337 · DOI 10.1038/s41392-021-00701-5
  2. The Role of PI3K Inhibition in the Treatment of Breast Cancer, Alone or Combined With Immune Checkpoint Inhibitors.
    Zhang Z, Richmond A. · · 2021 · cited 34× · PMID 34026830 · DOI 10.3389/fmolb.2021.648663
  3. PI3K/Akt Pathway: The Indestructible Role of a Vintage Target as a Support to the Most Recent Immunotherapeutic Approaches.
    Caforio M, de Billy E, De Angelis B, Iacovelli S, et al · · 2021 · cited 29× · PMID 34439194 · DOI 10.3390/cancers13164040
  4. Immune Checkpoint Blockade for the Treatment of Hodgkin Lymphoma.
    Lin AY, Schnitter JM, Gordon LI. · · 2022 · cited 14× · PMID 35237537 · DOI 10.2147/itt.s284988
  5. WNT signaling in cancer: molecular mechanisms and potential therapies.
    Liang J, Pan Y, Yang J, Zeng D, et al · · 2025 · cited 2× · PMID 41120801 · DOI 10.1186/s43556-025-00327-x
  6. Clinical efficacy and safety of umbralisib, a dual PI3Kδ/CK1-ϵ inhibitor, in treatment of hematologic malignancies.
    Zang Y, Cheng HE, Sun Y, Wang J, et al · · 2025 · PMID 41568384 · DOI 10.3389/fonc.2025.1591759

Verify or expand the search:

Other trials of Pembrolizumab

Trials testing the same drug.

Other recruiting trials for Hodgkin's Lymphoma

Currently open trials in the same condition.

Other University of Washington trials

Trials by the same sponsor.

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