A Study of Durvalumab (Anti-PDL1) Plus Radiation Therapy for the Treatment of Solitary Bone Plasmacytoma

NCT03196401 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: 17-269
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 6

Brief Summary

This study is being done to evaluate whether the combination of immune therapy and radiation therapy to plasmacytoma that can stimulate the immune system to attack and eliminate the abnormal cells in the bone marrow and perhaps delay or prevent the cancer from worsening. This study will evaluate whether the immune system responds to the combination of radiation with immunotherapy. It is possible that that the combination of immune therapy and radiation may not make any difference in whether or not the patient will develop multiple myeloma in the future.

Conditions

Solitary Bone Plasmacytoma

Keywords

Durvalumb; Radiation Therapy; Clonal Bone Marrow Plasmacytosis; MEDI4736; 17-269

Outcome Measures

Primary Outcomes (1)

• Response assessment

  Disease assessments are made according to IMWG criteria including criteria for minimal residual disease

  up to 36 months from start of cycle 1

Study Arms (1)

Durvalumab Plus Radiation Therapy

EXPERIMENTAL

Durvalumab (1500mg administered intravenously every 28 days), concurrently with definitive radiation therapy to the solitary bone plasmacytoma to start within 14 days of the first dose of durvalumab.

Drug: Durvalumab; Radiation: Radiation therapy

Interventions

Durvalumab DRUG

durvalumab 1500mg administered intravenously every 28 days, for a total of six doses

Also known as: (MEDI4736)

Durvalumab Plus Radiation Therapy

Radiation therapy RADIATION

concurrent definitive radiation therapy to the bone plasmacytoma initiated within two weeks of starting

Durvalumab Plus Radiation Therapy

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years
• Histologically confirmed plasmacytoma amenable for biopsy
• Detectable clonal bone marrow plasma cells by multicolor flow cytometry and less than 10% clonal plasma cells in a bone marrow biopsy by immunohistochemistry, morphology, or flow cytometry.
• Clinically safe to delay radiation for at least 2 weeks.
• ECOG performance status of 0-1.
• Anticipated lifespan greater than 3 month.
• Adequate organ function, as defined below:
• Total bilirubin within normal ranges unless associated with hepatobiliary metastases or Gilbert syndrome, then total bilirubin ≤ 2 x ULN
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN
• Creatinine ≤ 2.0 mg/dL
• Able and willing to give valid written informed consent.

You may not qualify if:

• Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis, Crohn's disease\], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener's syndrome \[granulomatosis with polyangiitis\]; myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis, uveitis; etc) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion: subjects with vitiligo or alopecia; subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement; or subjects with psoriasis not requiring systemic treatment.
• Current or prior use of immunosuppressive medication within 14 days prior to first dose of durvalumab. The following are exceptions to this criterion: intranasal, inhaled, topical or local steroid injections (eg. intra-articular injection); steroids as premedication for hypersensitivity reactions; systemic corticosteroid at physiologic doses not to exceed 10mg/day of prednisone or equivalent.
• Known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV).
• History of hypersensitivity to durvalumab or any excipient
• History of hypersensitivity to the combination or comparator agent (If applicable) Receipt of live attenuated vaccination within 30 days prior the first dose of durvalumab.
• Female subjects who are pregnant, breast-feeding or female patients of reproductive potential who are not employing an effective method of birth control from starting dose of durvalumab (Cycle 1 Day 1), including dosing interruptions through 90 days after receipt of the last dose of durvalumab. Refrain from egg cell donation while taking durvalumab and for at least 90 days after the last dose of durvalumab.
• Male subjects who are not employing an effective method of birth control from starting dose of durvalumab (Cycle 1 Day 1), including dosing interruptions through 90 days after receipt of the last dose of durvalumab. Refrain from sperm donation while taking durvalumab and for at least 90 days after the last dose of durvalumab.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Celgene Corporation: collaborator

Study Sites (6)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memoral Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Rockville Centre

Rockville Centre, New York, 11570, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Interventions

durvalumab; Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Alexander Lesokhin, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open-label, single center, single-arm pilot study of checkpoint blockade therapy (anti-PD-L1) plus radiation.

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: June 22, 2017
• Study Start: July 27, 2017
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: August 3, 2018

Record last verified: 2018-08

Locations

US (6)