Trial Outcomes & Findings for Nivolumab and the Antagonistic CSF-1R Monoclonal Antibody Cabiralizumab (BMS-986227) in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma (NCT NCT03927105)

Last Updated: 2024-03-18

Results Overview

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). * IR(1): ≥ 50% increase in overall tumor burden (sum of the product of the perpendicular diameters (SPD) of up to 6 target measurable nodes and extranodal sites) occurred in the 1st 12 weeks of therapy and without clinical deterioration * IR(2): new lesions or ≥ 50% increase of existing lesion(s) without a ≥ 50% increase of overall tumor burden at any time during treatment. * IR(3): increased FDG uptake of 1or more lesions without any increase in size or number of those lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

4 months

Results posted on

2024-03-18

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	4
Overall Study Began Treatment	3
Overall Study Follow-up	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Death	1
Overall Study In observation for potential re-treatment	2
Overall Study Subject was never treated due to new medical problems causing ineligibility prior to treatment.	1

Baseline Characteristics

Nivolumab and the Antagonistic CSF-1R Monoclonal Antibody Cabiralizumab (BMS-986227) in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nivolumab + Cabiralizumab n=4 Participants 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).
Age, Continuous	62.5 years n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	4 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	2 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants
Region of Enrollment United States	4 participants n=93 Participants

PRIMARY outcome

Timeframe: 4 months

Population: All subjects with measurable disease who received at least one cycle of treatment and had disease re-evaluated.

Outcome measures

Outcome measures
Measure	Nivolumab + Cabiralizumab n=3 Participants 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).
Overall Response Rate (ORR) at Four Months (LYRIC Criteria) Complete Response	2 Participants
Overall Response Rate (ORR) at Four Months (LYRIC Criteria) Partial Response	0 Participants
Overall Response Rate (ORR) at Four Months (LYRIC Criteria) Non-Responder	1 Participants

PRIMARY outcome

Timeframe: 4 months

Population: All subjects with measurable disease who received at least one cycle of treatment and had disease re-evaluated

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). * IR(1): ≥ 50% increase in overall tumor burden (sum of the product of the perpendicular diameters (SPD) of up to 6 target measurable nodes and extranodal sites) occurred in the 1st 12 weeks of therapy and without clinical deterioration * IR(2): new lesions or ≥ 50% increase of existing lesion(s) without a ≥ 50% increase of overall tumor burden at any time during treatment. * IR(3): increased FDG uptake of 1or more lesions without any increase in size or number of those lesions.

Outcome measures

Outcome measures
Measure	Nivolumab + Cabiralizumab n=3 Participants 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).
Complete Response Rate (CRR) at Four Months	2 Participants

SECONDARY outcome

Timeframe: four months

Population: All subjects with measurable disease who received at least one cycle of treatment and had disease re-evaluated

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.

Outcome measures

Outcome measures
Measure	Nivolumab + Cabiralizumab n=3 Participants 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).
Overall Response at Four Months by (LUGANO 2014) Criteria Complete Response	2 Participants
Overall Response at Four Months by (LUGANO 2014) Criteria Partial Response	0 Participants
Overall Response at Four Months by (LUGANO 2014) Criteria Non-Responder	1 Participants

SECONDARY outcome

Timeframe: four months

Population: All subjects with measurable disease who received at least one cycle of treatment and had disease re-evaluated

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.

Outcome measures

Outcome measures
Measure	Nivolumab + Cabiralizumab n=3 Participants 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).
Complete Response Rate at Four Months (LUGANO 2014) Criteria	2 Participants

Adverse Events

Nivolumab + Cabiralizumab

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Nivolumab + Cabiralizumab n=3 participants at risk 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).
Endocrine disorders ADRENAL INSUFFICIENCY	33.3% 1/3 • Number of events 1 • 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.
Infections and infestations ENDOCARDITIS INFECTIVE	33.3% 1/3 • Number of events 1 • 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.
Infections and infestations SEPSIS	33.3% 1/3 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	Nivolumab + Cabiralizumab n=3 participants at risk 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).
Eye disorders PERIORBITAL EDEMA	66.7% 2/3 • Number of events 5 • 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.
Gastrointestinal disorders ABDOMINAL PAIN	33.3% 1/3 • Number of events 1 • 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.
Gastrointestinal disorders DIARRHEA	33.3% 1/3 • Number of events 1 • 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.
Gastrointestinal disorders MUCOSITIS ORAL	33.3% 1/3 • Number of events 4 • 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.
Gastrointestinal disorders NAUSEA	33.3% 1/3 • Number of events 1 • 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.
Gastrointestinal disorders VOMITING	33.3% 1/3 • Number of events 1 • 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.
General disorders CHILLS	33.3% 1/3 • Number of events 1 • 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.
General disorders FATIGUE	66.7% 2/3 • Number of events 2 • 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.
General disorders FEVER	33.3% 1/3 • Number of events 1 • 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.
General disorders NON-CARDIAC CHEST PAIN	33.3% 1/3 • Number of events 1 • 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.
Infections and infestations INFECTIONS AND INFESTATIONS - OTHER, SPECIFY	33.3% 1/3 • Number of events 1 • 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.
Infections and infestations UPPER RESPIRATORY INFECTION	33.3% 1/3 • Number of events 2 • 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.
Investigations WEIGHT LOSS	33.3% 1/3 • Number of events 1 • 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.
Metabolism and nutrition disorders ANOREXIA	66.7% 2/3 • Number of events 2 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY	33.3% 1/3 • Number of events 1 • 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.
Nervous system disorders HEADACHE	33.3% 1/3 • Number of events 1 • 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.
Psychiatric disorders INSOMNIA	33.3% 1/3 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders COUGH	33.3% 1/3 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	33.3% 1/3 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders SORE THROAT	33.3% 1/3 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders PRURITUS	33.3% 1/3 • Number of events 1 • 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.

Additional Information

Adelai Neal

Hoosier Cancer Research Network

Phone: 317-921-2053

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place