Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
A multicenter trial evaluating the combination of nivolumab and the antagonistic CSF-1R monoclonal antibody cabiralizumab (BMS-986227) in patients with relapsed/refractory peripheral T cell lymphoma
Enrollment to this study was discontinued after four subjects due to industry-related changes to the Cabiralizumab program.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab + Cabiralizumab | Experimental | Nivolumab 240mg IV + Cabiralizumab 4mg/kg on day 1 of every 14 day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | Nivolumab is a human monoclonal antibody (HuMAb; immunoglobulin G4 [IgG4]-S228P) that targets the programmed death-1 (PD-1) cluster of differentiation 279 (CD279) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.1 Binding of PD-1 to its ligands, programmed death-ligands 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Inhibition of the interaction between PD-1 and its ligands promotes immune responses and antigen-specific T-cell responses to both foreign antigens as well as self-antigens. Nivolumab will be delivered intravenously at a fixed dose of 240 mg on day 1 of 14 day cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) at Four Months (LYRIC Criteria) | Overall Response Rate (CR + PR) as determined by LYRIC (LYmphoma Response to Immunomodulatory therapy Criteria), at four months (shown as number of participants with CR or PR at 4 months). LYRIC: An adaptation of the Lugano classification developed because discriminating true progressive disease from pseudoprogression in lymphoma patients receiving immunomodulatory agents is challenging. To address this challenge, the LYRIC criteria incorporated the response category of "indeterminate response" (IR).
| 4 months |
| Complete Response Rate (CRR) at Four Months | Complete response rate, as determined by LYRIC criteria, at four months (reported as number of participants with CR at 4 months). LYRIC: An adaptation of the Lugano classification developed because discriminating true progressive disease from pseudoprogression in lymphoma patients receiving immunomodulatory agents is challenging. To address this challenge, the LYRIC criteria incorporated the response category of "indeterminate response" (IR).
| 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response at Four Months by (LUGANO 2014) Criteria | Overall response (CR + PR), as determined by LUGANO 2014 criteria (reported as number of participants with a CR or PR at 4 months). The Lugano classification is utilized for both lymphoma staging and response assessment and incorporates PET-CT imaging. Responses are described as either partial or complete, with a complete response requiring disappearance of metabolically active sites of disease. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
PTCL histology consistent with ATLL.
A history of, or a concurrent, clinically significant illness, medical condition or laboratory abnormality that, in the investigator's opinion, could affect the conduct of the study.
Active infection requiring systemic therapy
Recent (<100 days) autologous stem cell transplant, or previous allogeneic stem cell transplant.
Known positive test for HIV. NOTE: HIV screening is not required.
History of any chronic hepatitis as evidenced by the following:
Pregnant or breastfeeding. NOTE: breast milk cannot be stored for future use while the mother is being treated on study.
Previous malignancies (except non-melanoma skin cancers and in situ bladder, gastric, colorectal, endometrial, cervical/dysplasia, melanoma, or breast cancers) unless complete remission was achieved at least 2 years prior to study entry and no additional therapy is required during the study period.
Prior treatment with cabiralizumab (or other CSF1R pathway inhibitors).
Prior treatment with nivolumab or other medications within the checkpoint blockade family.
Any unregulated nutritional or herbal supplement or recreational drug within 2 weeks prior to registration which, in the opinion of the study investigator, has the potential to cause hepatic injury.
Concomitant use of statins for treatment of hypercholesterolemia. Statins are allowed only if the patient is on a stable dose for over 3 months prior to study registration and is in a stable status without CK elevations.
Non-oncology vaccine therapies for prevention of infectious diseases (e.g., human papilloma virus vaccine) within 4 weeks of study registration. The inactivated seasonal influenza vaccine can be given to patients before treatment and while on therapy without restriction. Influenza vaccines containing live virus or other clinically indicated vaccinations for infectious diseases (i.e., pneumovax, varicella, etc.) may be permitted, but must be discussed with the sponsor investigator and may require a study drug washout period before and after administration of vaccine.
Known history of sensitivity to infusions containing Tween 20 (polysorbate 20) and Tween 80 (polysorbate 80)
History of allergy to any components of cabiralizumab or nivolumab
Active, known, or suspected autoimmune disease.
Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity.
Current or history of clinically significant muscle disorders (e.g., myositis), recent unresolved muscle injury, or any condition known to elevate serum CK levels.
Uncontrolled or significant cardiovascular disease including, but not limited to, any of the following:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ryan Wilcox, MD, PhD | University of Michigal Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States | ||
| Ohio State University Comprehensive Cancer Center |
Not provided
Not provided
Not provided
Not provided
Not provided
One participant consented, was deemed eligible, and enrolled to the trial, however subject was never treated due to new medical problems causing ineligibility prior to treatment.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Nivolumab + Cabiralizumab | Nivolumab is a human monoclonal antibody (HuMAb; immunoglobulin G4 [IgG4]-S228P) that targets the programmed death-1 (PD-1) cluster of differentiation 279 (CD279) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.1 Binding of PD-1 to its ligands, programmed death-ligands 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Inhibition of the interaction between PD-1 and its ligands promotes immune responses and antigen-specific T-cell responses to both foreign antigens as well as self-antigens. Nivolumab will be delivered intravenously at a fixed dose of 240 mg on day 1 of 14 day cycles. Cabiralizumab is a recombinant, humanized Immunoglobulin G4 (IgG4) monoclonal antibody that binds to human colony stimulating factor 1 receptor (CSF1R; c-fms). Cabiralizumab will be delivered intravenously at a dosage of 4 mg/kg on day 1 of 14 day cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| cabiralizumab | Drug | Cabiralizumab is a recombinant, humanized Immunoglobulin G4 (IgG4) monoclonal antibody that binds to human colony stimulating factor 1 receptor (CSF1R; c-fms). Cabiralizumab will be delivered intravenously at a dosage of 4 mg/kg on day 1 of 14 day cycles. |
|
|
| four months |
| Complete Response Rate at Four Months (LUGANO 2014) Criteria | Complete Response Rate, as determined by LUGANO 2014 criteria, at (reported as number of participants with a CR at 4 months). The Lugano classification is utilized for both lymphoma staging and response assessment and incorporates PET-CT imaging. A complete response requires disappearance of metabolically active sites of disease. | four months |
| Progression-Free Survival (PFS) | Progression-Free Survival will be measured as number of patients alive at 3, 6, 9 and 12 months. | 3, 6, 9 and 12 months post starting study treatment |
| Disease Control Rate (DCR) | The proportion of all subjects with stable disease (SD) for 8 weeks, PR, or CR. | at time of study drug discontinuation, average of 7 months |
| Duration of Response (DOR) | Duration of Response measured from the time that measurement criteria are met for CR or PR (whichever status is recorded first) until the date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since treatment started). | at time of study drug discontinuation, up to 3 years |
| Time to Next Treatment (TNT) | Time to next treatment (TNT) is defined as the time from the date of enrollment to the institution of next treatment. | Up to 1 year post discontinuation of therapy, average of 24 months |
| Summarize Adverse Events | Assess and summarize adverse events (AEs) using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5. | From time of consent through 100 days post treatment discontinuation. Longest actual collection for AEs: 13 months. Average of 9.5 Months |
| Columbus |
| Ohio |
| 43210 |
| United States |
| Unviersity of Wisconsin | Madison | Wisconsin | 53705 | United States |
| Began Treatment |
|
| Follow-up |
|
| COMPLETED | completed through primary outcome measure collection; two participants are still in observation for secondary outcome measure assessments (not yet completed). |
|
| NOT COMPLETED |
|
|
All subject consented, confirmed to be eligible, and registered to the trial.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nivolumab + Cabiralizumab | Nivolumab 240mg IV + Cabiralizumab 4mg/kg on day 1 of every 14 day cycle. Nivolumab is a human monoclonal antibody (HuMAb; immunoglobulin G4 [IgG4]-S228P) that targets the programmed death-1 (PD-1) cluster of differentiation 279 (CD279) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.1 Binding of PD-1 to its ligands, programmed death-ligands 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Inhibition of the interaction between PD-1 and its ligands promotes immune responses and antigen-specific T-cell responses to both foreign antigens as well as self-antigens. Cabiralizumab is a recombinant, humanized Immunoglobulin G4 (IgG4) monoclonal antibody that binds to human colony stimulating factor 1 receptor (CSF1R; c-fms). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) at Four Months (LYRIC Criteria) | Overall Response Rate (CR + PR) as determined by LYRIC (LYmphoma Response to Immunomodulatory therapy Criteria), at four months (shown as number of participants with CR or PR at 4 months). LYRIC: An adaptation of the Lugano classification developed because discriminating true progressive disease from pseudoprogression in lymphoma patients receiving immunomodulatory agents is challenging. To address this challenge, the LYRIC criteria incorporated the response category of "indeterminate response" (IR).
| All subjects with measurable disease who received at least one cycle of treatment and had disease re-evaluated. | Posted | Count of Participants | Participants | 4 months |
|
|
| ||||||||||||||||||||||||||||||
| Primary | Complete Response Rate (CRR) at Four Months | Complete response rate, as determined by LYRIC criteria, at four months (reported as number of participants with CR at 4 months). LYRIC: An adaptation of the Lugano classification developed because discriminating true progressive disease from pseudoprogression in lymphoma patients receiving immunomodulatory agents is challenging. To address this challenge, the LYRIC criteria incorporated the response category of "indeterminate response" (IR).
| All subjects with measurable disease who received at least one cycle of treatment and had disease re-evaluated | Posted | Count of Participants | Participants | 4 months |
| ||||||||||||||||||||||||||||||||
| Secondary | Overall Response at Four Months by (LUGANO 2014) Criteria | Overall response (CR + PR), as determined by LUGANO 2014 criteria (reported as number of participants with a CR or PR at 4 months). The Lugano classification is utilized for both lymphoma staging and response assessment and incorporates PET-CT imaging. Responses are described as either partial or complete, with a complete response requiring disappearance of metabolically active sites of disease. | All subjects with measurable disease who received at least one cycle of treatment and had disease re-evaluated | Posted | Count of Participants | Participants | four months |
| ||||||||||||||||||||||||||||||||
| Secondary | Complete Response Rate at Four Months (LUGANO 2014) Criteria | Complete Response Rate, as determined by LUGANO 2014 criteria, at (reported as number of participants with a CR at 4 months). The Lugano classification is utilized for both lymphoma staging and response assessment and incorporates PET-CT imaging. A complete response requires disappearance of metabolically active sites of disease. | All subjects with measurable disease who received at least one cycle of treatment and had disease re-evaluated | Posted | Count of Participants | Participants | four months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | Progression-Free Survival will be measured as number of patients alive at 3, 6, 9 and 12 months. | Posted | Count of Participants | Participants | 3, 6, 9 and 12 months post starting study treatment |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | The proportion of all subjects with stable disease (SD) for 8 weeks, PR, or CR. | Posted | Count of Participants | Participants | at time of study drug discontinuation, average of 7 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | Duration of Response measured from the time that measurement criteria are met for CR or PR (whichever status is recorded first) until the date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since treatment started). | two patients responded to treatment as defined by the protocol | Posted | Median | Full Range | months | at time of study drug discontinuation, up to 3 years |
| |||||||||||||||||||||||||||||||
| Secondary | Time to Next Treatment (TNT) | Time to next treatment (TNT) is defined as the time from the date of enrollment to the institution of next treatment. | Data was not collected. Study was conducted through BTCRC and was not collected. No data is available to be analyzed and will never become available. | Posted | Up to 1 year post discontinuation of therapy, average of 24 months |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Summarize Adverse Events | Assess and summarize adverse events (AEs) using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5. | Posted | Number | number of events | From time of consent through 100 days post treatment discontinuation. Longest actual collection for AEs: 13 months. Average of 9.5 Months |
|
|
From time of consent through 100 days post treatment discontinuation. Longest actual collection for AEs: 13 months
An AE is any untoward medical occurrence whether or not related to the study drug that appears to change in intensity during the course of the study.
Abnormal laboratory values or diagnostic test results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests Hospitalization for elective surgery or routine clinical procedures that are not the result of an AE (e.g.,surgical insertion of central line) should not be recorded as an AE.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nivolumab + Cabiralizumab | Nivolumab 240mg IV + Cabiralizumab 4mg/kg on day 1 of every 14 day cycle. Nivolumab is a human monoclonal antibody (HuMAb; immunoglobulin G4 [IgG4]-S228P) that targets the programmed death-1 (PD-1) cluster of differentiation 279 (CD279) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.1 Binding of PD-1 to its ligands, programmed death-ligands 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Inhibition of the interaction between PD-1 and its ligands promotes immune responses and antigen-specific T-cell responses to both foreign antigens as well as self-antigens. Cabiralizumab is a recombinant, humanized Immunoglobulin G4 (IgG4) monoclonal antibody that binds to human colony stimulating factor 1 receptor (CSF1R; c-fms). | 1 | 3 | 2 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ADRENAL INSUFFICIENCY | Endocrine disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ENDOCARDITIS INFECTIVE | Infections and infestations | CTCAEv5 | Non-systematic Assessment |
| |
| SEPSIS | Infections and infestations | CTCAEv5 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PERIORBITAL EDEMA | Eye disorders | CTCAEv5 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| DIARRHEA | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| MUCOSITIS ORAL | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| CHILLS | General disorders | CTCAEv5 | Non-systematic Assessment |
| |
| FATIGUE | General disorders | CTCAEv5 | Non-systematic Assessment |
| |
| FEVER | General disorders | CTCAEv5 | Non-systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | CTCAEv5 | Non-systematic Assessment |
| |
| INFECTIONS AND INFESTATIONS - OTHER, SPECIFY | Infections and infestations | CTCAEv5 | Non-systematic Assessment |
| |
| UPPER RESPIRATORY INFECTION | Infections and infestations | CTCAEv5 | Non-systematic Assessment |
| |
| WEIGHT LOSS | Investigations | CTCAEv5 | Non-systematic Assessment |
| |
| ANOREXIA | Metabolism and nutrition disorders | CTCAEv5 | Non-systematic Assessment |
| |
| NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAEv5 | Non-systematic Assessment | Liposarcoma |
|
| HEADACHE | Nervous system disorders | CTCAEv5 | Non-systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | CTCAEv5 | Non-systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| SORE THROAT | Respiratory, thoracic and mediastinal disorders | CTCAEv5 | Non-systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | CTCAEv5 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adelai Neal | Hoosier Cancer Research Network | 317-921-2053 | aneal@hoosiercancer.org |
| Aug 12, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| C000722457 | cabiralizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|