Pembrolizumab in Neoplasms or Lymphomas

NCT03316573 | Suspended Phase 2 Results DMC FDA Drug

• 1 other identifier: 17-448
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief Summary

This research study is studying a drug called pembrolizumab as a possible treatment for aggressive lymphoma or a histiocyte or dendritic cell neoplasm. The drug involved in this study is:

• Pembrolizumab

Conditions

Lymphoma; Histiocytic Sarcoma; Follicular Dendritic Cell Sarcoma; Interdigitating Dendritic Cell Sarcoma

Keywords

Lymphoma; Histiocyte sarcoma; Follicular Dendritic Cell Sarcoma; Interdigitating dendritic cell sarcoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  The number of subjects with partial response (PR) or complete response (CR) by PET/CT scan Per Lugano criteria, CR is defined as positron emission tomography-computed tomography (PET-CT), score 1, 2, or 3 with or without a residual mass on 5 point scale (5PS) OR on CT, target nodes/nodal masses must regress to ≤1.5 cm in longest diameter (LDi). PR is defined as PET-CT score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size. OR on CT ≥50% decrease in the sum of the products of the longest perpendicular diameters (SPD) of up to 6 target measurable nodes and extranodal sites.

  2 years

Secondary Outcomes (6)

• Complete Response Rate

  2 years

• Number of Patients With Adverse Events of Any Grade

  Up to 35 cycles of treatment (approximately 2 years) plus up to an additional 24 months of follow-up after treatment

• Duration of Response

  Up to 35 cycles of treatment (approximately 2 years) plus up to an additional 24 months of follow-up after treatment

• Progression-free Survival

  Up to 35 cycles of treatment (approximately 2 years) plus up to an additional 24 months of follow-up after treatment

• Duration of Complete Response

  Up to 35 cycles of treatment (approximately 2 years) plus up to an additional 24 months of follow-up after treatment

Study Arms (1)

Pembrolizumab

EXPERIMENTAL

Pembrolizumab will be administered intravenously every 3 weeks for 35 cycles

Drug: Pembrolizumab

Interventions

Pembrolizumab DRUG

The study drug is an antibody that targets a molecule called PD-1. Blocking PD-1 allow the immune system to attack the cancer more effectively.

Also known as: Keytruda

Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be willing and able to provide written informed consent for the trial.
• Histologically confirmed diagnosis of a histiocyte/dendritic cell neoplasm or relapsed/refractory aggressive lymphoma with at least one of the following features (with review required at a participating study center):
• Diffuse large B cell lymphoma with Epstein-Barr virus (EBV) positive tumor cells (defined as positive EBV-encoded RNA in tumor cells)
• Plasmablastic lymphoma
• T cell/histiocyte rich DLBCL
• EBV+ T cell lymphoma of any histology; note, patients with angioimmunoblastic T cell lymphoma will be eligible regardless of EBV status
• Histiocytic sarcoma
• Follicular dendritic cell sarcoma
• Interdigitating dendritic cell sarcoma
• For patients with histiocytic sarcoma, interdigitating dendritic cell sarcoma, or follicular dendritic cell sarcoma only: disease that is not amenable to surgical resection and/or radiation therapy with curative intent.
• For lymphoma patients only: At least one prior systemic chemotherapy including an alkylating agent and anthracycline (unless contraindicated), and an anti-cluster of differentiate 20 (CD20) monoclonal antibody if the tumor is CD20+.
• For lymphoma patients only: Participants must have received and relapsed after autologous stem cell transplantation (ASCT), or be ineligible for ASCT (including on the basis of refractory disease), or have declined ASCT
• Age 18 years or older at the time of signing consent.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky ≥70%, see Appendix A)
• Participants must have normal organ and marrow function as defined below:

You may not qualify if:

• Prior treatment with a PD-1, PD-L1 or PD-L2 inhibitor
• Has had a prior anti-cancer monoclonal antibody within 4 weeks prior to study day 1 or has not recovered (i.e., \< grade 1 or at baseline) from adverse events due to a previously administered agent.
• Participants who have had chemotherapy, targeted small molecule therapy, or radiotherapy within 2 weeks prior to study day 1 (6 weeks for nitrosoureas or mitomycin C) or who has not recovered (i.e., \< grade 1 or at baseline) from adverse events due to previously administered agents. Note: subjects with \< grade 2 peripheral neuropathy are an exception to this criterion and may qualify for the study.
• Radiation therapy within 2 weeks of study treatment
• Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
• Has a known history of active tuberculosis
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Has an active infection requiring systemic therapy.
• Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with the use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal her pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Has a diagnosis of immunodeficiency or is receiving any form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment or is taking chronic systemic steroids (in doses exceeding 10 mg daily of prednisone equivalent) within 7 days prior to the first dose of trial treatment. Note: Subjects with asthma or chronic obstructive pulmonary disease that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections are not excluded from the study.
• Has a history of non-infectious pneumonitis that required systemic corticosteroid treatment or has active pneumonitis.
• Known active central nervous system involvement and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
• Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
• Active hepatitis B (e.g., hepatitis B surface antigen reactive) or hepatitis C (e.g., hepatitis C virus RNA detectable).
• Human immunodeficiency virus (HIV 1/2).

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (4)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Nebraska

Omaha, Nebraska, 68198, United States

Location

Related Publications (1)

• Griffin GK, Weirather JL, Roemer MGM, Lipschitz M, Kelley A, Chen PH, Gusenleitner D, Jeter E, Pak C, Gjini E, Chapuy B, Rosenthal MH, Xu J, Chen BJ, Sohani AR, Lovitch SB, Abramson JS, Ishizuka JJ, Kim AI, Jacobson CA, LaCasce AS, Fletcher CD, Neuberg D, Freeman GJ, Hodi FS, Wright K, Ligon AH, Jacobsen ED, Armand P, Shipp MA, Rodig SJ. Spatial signatures identify immune escape via PD-1 as a defining feature of T-cell/histiocyte-rich large B-cell lymphoma. Blood. 2021 Mar 11;137(10):1353-1364. doi: 10.1182/blood.2020006464.

  PMID: 32871584 DERIVED

MeSH Terms

Conditions

Lymphoma; Histiocytic Sarcoma; Dendritic Cell Sarcoma, Follicular; Dendritic Cell Sarcoma, Interdigitating

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Histiocytic Disorders, Malignant; Histiocytosis

Results Point of Contact

• Title: Eric Jacobsen, MD
• Organization: Dana-Farber Cancer Institute

edjacobsen@partners.org

617-632-6633

Study Officials

• Eric Jacobsen, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 20, 2017
• Study Start: December 7, 2017
• Primary Completion: August 18, 2022
• Study Completion: March 1, 2026
• Last Updated: February 10, 2026
• Results First Posted: November 22, 2023

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)