Nivolumab and Tocilizumab for Relapsed Hematological Malignancy Post-allogeneic Transplant
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|ClinicalTrials.gov Identifier: NCT03588936|
Recruitment Status : Recruiting
First Posted : July 17, 2018
Last Update Posted : August 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Leukemia Chronic Leukemia Lymphoma Myelodysplastic Syndromes||Drug: Nivolumab Drug: Tocilizumab||Phase 1|
Study disease: Hematologic malignancies including, but not exclusive to,acute/chronic leukemia, lymphoma, and myelodysplastic syndrome that has relapsed after allogeneic transplant.
Study Rationale: Phase 1 Safety/Dose Finding Study: To determine the safety and maximum tolerated dose of Nivolumab in combination with Tocilizumab.
Study Agent Description:
Tocilizumab is a monoclonal antibody and immunosuppressant; specifically, tocilizumab is an interleukin-6 (IL-6) receptor antagonist.
Nivolumab is a human immunoglobulin IgG4 monoclonal antibody that binds to the PD-1 receptor of T cells blocking its interaction with PD-L1 and PD-L2, thereby enhancing T-cell proliferation and allowing the immune system to attack the tumor.
Number of Subjects: A maximum of 12 patients will be enrolled on this Phase 1 study.
Duration of Follow-up: Patients will be followed for up to one year post-treatment for survival and response.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study of Nivolumab in Combination With Tocilizumab for Treatment of Patients With Relapsed Hematological Malignancies Post-allogeneic Transplant|
|Actual Study Start Date :||September 14, 2018|
|Estimated Primary Completion Date :||August 1, 2021|
|Estimated Study Completion Date :||August 1, 2022|
Experimental: Nivolumab and Tocilizumab
Patient will receive tocilizumab 8 mg/kg IV (max dose 800 mg) on Day 0. On Day 1 patients will receive nivolumab IV (0.25 mg/kg or 0.5 mg/kg based on dose escalation design).
Nivolumab will be given every ~2 weeks for up to 4 doses and a second dose of Tocilizumab will be given on ~Day 29 on the same day as Dose # 3 of Nivolumab.
Patients will receive Nivolumab at one of two dose levels every 2 weeks for 4 treatments.
Other Name: OPDIVO
Patients will receive 2 doses of tocilizumab
Other Name: ACTEMRA
- Maximum Tolerated Dose among Two Candidate Doses of Nivolumab in Combination with Tocilizumab [ Time Frame: Up to 4 weeks after last dose of study treatment (approximately 3 months) ]Determine the safety and the maximum tolerated dose among two candidate doses of nivolumab in combination with tocilizumab for treatment of relapsed hematological malignancy post-allogeneic transplant. This will be measured by the number of adverse events as defined by the NCI CTCAE version 4.03 non-hematologic ≥ grade 3-5 signs/symptoms or by the development of steroid refractory grade 2-4 graft-versus-host disease or severe chronic graft-versus-host disease
- Response Rates [ Time Frame: Evaluate at the end of study treatment (approximately 2 months) ]Since patients with a variety of histologies will be treated - response will be assessed using disease appropriate imaging/marrow and international consensus criteria most applicable to the disease.
- Overall Survival [ Time Frame: Up to 1 year from beginning of treatment ]Will measure survival of patients after treatment
- Progression Free Survival [ Time Frame: Up to 1 year from beginning of treatment ]Determine the number of patients alive and in remission after treatment
- Duration of response in responding patients [ Time Frame: Up to 1 year from the beginning of treatment ]Time that a patient's disease remains stable
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03588936
|Contact: Medical College of Wisconsin Cancer Center Clinical Trials Officefirstname.lastname@example.org|
|United States, Wisconsin|
|Froedtert Hospital and the Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Froedtert Hospital and the Medical College of Wisconsin 866-680-0505 ext 8900 email@example.com|
|Principal Investigator:||Nirav Shah, MD||Medical College of Wisconsin|