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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03196401

Collaborator

Celgene Corporation (Industry)

Enrollment

Locations

Arm

34.2

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solitary Bone Plasmacytoma	Drug: Durvalumab Radiation: Radiation therapy	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Pilot Study to Evaluate for the Abscopal Effect of Durvalumab (Anti-PD-L1) in Combination With Definitive Radiation Therapy in Solitary Bone Plasmacytoma With Limited Clonal Bone Marrow Plasmacytosis

Actual Study Start Date :

Jul 27, 2017

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Durvalumab Plus Radiation Therapy 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 durvalumab 1500mg administered intravenously every 28 days, for a total of six doses Other Names: (MEDI4736) Radiation: Radiation therapy concurrent definitive radiation therapy to the bone plasmacytoma initiated within two weeks of starting

Arm

Intervention/Treatment

Experimental: Durvalumab Plus Radiation Therapy

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

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

Other Names:

(MEDI4736)

Radiation: Radiation therapy

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

Outcome Measures

Primary Outcome Measures

Response assessment [up to 36 months from start of cycle 1]
Disease assessments are made according to IMWG criteria including criteria for minimal residual disease

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey	United States	07920
2	Memoral Sloan Kettering Monmouth	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Commack	Commack	New York	United States	11725
4	Memorial Sloan Kettering Westchester	Harrison	New York	United States	10604
5	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
6	Memorial Sloan Kettering Rockville Centre	Rockville Centre	New York	United States	11570