Study of the PD-L1 Inhibitor Atezolizumab With or Without Low-dose, Local Radiation in Patients With Relapsed or Refractory Advanced Stage Follicular Lymphoma

NCT03465891 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 17-360
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to compare the safety and effects of atezolizumab with low dose radiation on people with relapsed or refractory follicular lymphoma, In this study, the patient will get either atezolizumab with low dose radiation or, atezolizumab alone. To be better, the atezolizumab and low dose radiation should increase life by 1 year or more compared to the usual approach.

Conditions

Lymphoma

Keywords

Advanced Stage Follicular Lymphoma; Relapsed; Refractory; Atezolizumab; Dose Local Radiotherapy (2 x 2Gy); 17-360

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  objective response defined as CR or PR; as measured in non-irradiated sites of disease. Response will be assessed by the investigator per the Lugano Classification.

  3 years

Study Arms (2)

atezolizumab

EXPERIMENTAL

All patients will receive open-label atezolizumab 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year).

Drug: atezolizumab

atezolizumab plus low-dose, local radiotherapy

EXPERIMENTAL

All patients will receive open-label atezolizumab 1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year). 4Gy will be administered in 2 fractions to a single nodal site amenable to radiation as identified by the radiation oncologist on day 2 and day 3 of Cycle 1 (over the two days following to the first dose of atezolizumab ).

Drug: atezolizumab; Radiation: Low- Dose, Local Radiotherapy

Interventions

atezolizumab DRUG

1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year).

atezolizumab; atezolizumab plus low-dose, local radiotherapy

Low- Dose, Local Radiotherapy RADIATION

4Gy will be administered in 2 fractions to a single nodal site amenable to radiation as identified by the radiation oncologist on day 2 and day 3 of Cycle 1 (over the two days following to the first dose of atezolizumab ).

atezolizumab plus low-dose, local radiotherapy

Eligibility Criteria

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

You may qualify if:

• Signed Informed Consent Form (ICF) Ability and willingness to comply with the requirements of the study protocol
• Age ≥ 18 years
• Relapsed or refractory follicular lymphoma grade 1, 2, or 3A
• Relapsed disease is defined as having relapsed after greater than 6 months of prior treatment for follicular lymphoma
• Refractory disease is defined as failure to achieve a complete response or relapsed within 6 months of treatment for follicular lymphoma
• Pretreatment biopsy for fresh tumor tissue collection is required
• If patient has recently undergone a biopsy and has not received any intercurrent anti-lymphoma therapy, archival tissue can be used
• Stage III/IV disease
• ° Stage II disease is also eligible if disease is not encompassible within a single radiation field, as determined by the radiation oncologist
• At least 1 prior treatment for follicular lymphoma (no restriction to number or type of prior therapies)
• Patient treated for transformed diffuse large B cell lymphoma (DLBCL) who have retrograde transformation are eligible provided they have received at least one prior treatment for the follicular lymphoma
• Site of disease amenable to low-dose, local radiotherapy (2 x 2Gy), as recommended by the radiation oncologist
• At least one bi-dimensionally measurable nodal lesion \> 1.5 cm in its longest diameter by CT scan or magnetic resonance imaging, as defined by the Lugano Classification
• Adequate hematologic and end organ function:
• ANC ≥ 1500 cells/µL

You may not qualify if:

• Follicular lymphoma grade 3B
• Concurrent aggressive non-Hodgkin lymphoma (e.g. diffuse large B cell lymphoma \[DLBCL\])
• Any anticancer therapy, including chemotherapy, hormonal therapy, investigational therapy, or radiotherapy, within 3 weeks, or 5 half lifes, whichever is shortest, prior to initiation of study treatment. However, the following are allowed:
• Hormone-replacement therapy or oral contraceptives
• Herbal therapy, provided it is discontinued at least 1 week prior to Cycle 1, Day 1
• Palliative radiotherapy for bone metastases, provided most recent fraction not given within 2 weeks of Cycle 1, Day 1 and most recent fraction was not administered to planned area of radiation while on study.
• AEs from prior anticancer therapy that have not resolved to Grade ≤ 1 with exception of alopecia or skin/nail hyperpigmentation
• Bisphosphonate therapy for symptomatic hypercalcemia within 2 weeks of cycle 1, day 1
• ° Use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed. Denosumab should not be used while on therapy
• Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease
• Active central nervous system (CNS) involvement of lymphoma
• ° Patients with a history of CNS involvement of lymphoma are eligible, provided they received treatment greater than 30 days prior to cycle 1 day 1 and there is no evidence of involvement on most recent assessment
• Pregnant, or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of study treatment.
• ° Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment
• Known hypersensitivity to Chinese hamster ovary cell products, other recombinant human antibodies, or to any component of the atezolizumab formulation

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (6)

Memoral 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 Nassau

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Lymphoma; Recurrence

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Lia Palomba
• Organization: Memorial Sloan Kettering Cancer Center

palombam@mskcc.org

646-608-3711

Study Officials

• M. Lia Palomba, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a two-arm, parallel, open-label, phase II clinical trial.

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: March 14, 2018
• Study Start: March 9, 2018
• Primary Completion: December 17, 2019
• Study Completion: December 17, 2019
• Last Updated: January 12, 2021
• Results First Posted: January 12, 2021

Record last verified: 2019-12

Locations

US (6)