Trial Outcomes & Findings for Safety and Immunotherapeutic Activity of an Anti-PD-1 Antibody (Cemiplimab) in Participants With HIV-1 on Suppressive cART (NCT NCT03787095)
NCT ID: NCT03787095
Last Updated: 2022-03-02
Results Overview
Relationship to study treatment was judged by the Clinical Management Committee (CMC), blinded to treatment arm. Immune-related AEs include, but were not limited to, pneumonitis, colitis, adrenal insufficiency, or hypothyroidism. Adverse events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017. Infusion reactions, adrenal insufficiency, and pneumonitis were graded per the National Cancer Institute's (NCI) Common Terminology Criteria for AEs (CTCAE), Version 5.0 guidelines
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Study Entry through Week 48 or premature discontinuation
Results posted on
2022-03-02
Participant Flow
The first participant was enrolled in August 2019. The final participant was enrolled in September 2019. The study was paused to accrual for emergency review by the study monitoring committee (SMC) in October 2019, followed by the decision to close the study later that month. Participants were recruited from 3 sites in the US.
Participant milestones
| Measure |
Cohort 1: Cemiplimab
Participants received 0.3 mg/kg of cemiplimab, with planned administration at Day 0 and Week 6 for a total of two infusions.
Participants continued their current non-study provided ART regimen.
Cemiplimab: Administered as an intravenous (IV) infusion
|
Cohort 1: Placebo
Participants received placebo, with planned administration at Day 0 and Week 6 for a total of two infusions.
Participants continued their current non-study provided ART regimen.
Placebo: Diluent for REGN2810 , administered as an IV infusion
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
1
|
|
Overall Study
COMPLETED
|
4
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Immunotherapeutic Activity of an Anti-PD-1 Antibody (Cemiplimab) in Participants With HIV-1 on Suppressive cART
Baseline characteristics by cohort
| Measure |
Cohort 1: Cemiplimab
n=4 Participants
Participants received 0.3 mg/kg of cemiplimab, with planned administration at Day 0 and Week 6 for a total of two infusions.
Participants continued their current non-study provided ART regimen.
Cemiplimab: Administered as an intravenous (IV) infusion
|
Cohort 1: Placebo
n=1 Participants
Participants received placebo, with planned administration at Day 0 and Week 6 for a total of two infusions.
Participants continued their current non-study provided ART regimen.
Placebo: Diluent for REGN2810 , administered as an IV infusion
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
n=5 Participants
|
52 years
n=7 Participants
|
51 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
CD4 Count
|
1151 cells/mm^3
n=5 Participants
|
348 cells/mm^3
n=7 Participants
|
911 cells/mm^3
n=5 Participants
|
|
CD8 Count
|
1516 cells/mm^3
n=5 Participants
|
286 cells/mm^3
n=7 Participants
|
1508 cells/mm^3
n=5 Participants
|
|
CD4/CD8 ratio
|
0.90 ratio
n=5 Participants
|
1.22 ratio
n=7 Participants
|
0.91 ratio
n=5 Participants
|
|
HIV-1 RNA
<40 copies/mL
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
HIV-1 RNA
>=40 copies/mL
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Weight
|
88.8 kilograms
n=5 Participants
|
101.0 kilograms
n=7 Participants
|
90.7 kilograms
n=5 Participants
|
PRIMARY outcome
Timeframe: Study Entry through Week 48 or premature discontinuationPopulation: All participants
Relationship to study treatment was judged by the Clinical Management Committee (CMC), blinded to treatment arm. Immune-related AEs include, but were not limited to, pneumonitis, colitis, adrenal insufficiency, or hypothyroidism. Adverse events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017. Infusion reactions, adrenal insufficiency, and pneumonitis were graded per the National Cancer Institute's (NCI) Common Terminology Criteria for AEs (CTCAE), Version 5.0 guidelines
Outcome measures
| Measure |
Cohort 1: Cemiplimab
n=4 Participants
Participants received 0.3 mg/kg of cemiplimab, with planned administration at Day 0 and Week 6 for a total of two infusions.
Participants continued their current non-study provided ART regimen.
Cemiplimab: Administered as an intravenous (IV) infusion
|
Cohort 1: Placebo
n=1 Participants
Participants received placebo, with planned administration at Day 0 and Week 6 for a total of two infusions.
Participants continued their current non-study provided ART regimen.
Placebo: Diluent for REGN2810 , administered as an IV infusion
|
|---|---|---|
|
Count of Participants With a Grade >=3 Adverse Event (AE) or Grade >=1 Immune-related AE (irAE) Related to Study Treatment
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Study Entry through Week 48 or premature discontinuationPopulation: All participants.
Relationship to study treatment was judged by the Clinical Management Committee (CMC), blinded to treatment arm. Immune-related AEs include, but were not limited to, pneumonitis, colitis, adrenal insufficiency, or hypothyroidism. Adverse events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017. Infusion reactions, adrenal insufficiency, and pneumonitis were graded per the National Cancer Institute's (NCI) Common Terminology Criteria for AEs (CTCAE), Version 5.0 guidelines
Outcome measures
| Measure |
Cohort 1: Cemiplimab
n=4 Participants
Participants received 0.3 mg/kg of cemiplimab, with planned administration at Day 0 and Week 6 for a total of two infusions.
Participants continued their current non-study provided ART regimen.
Cemiplimab: Administered as an intravenous (IV) infusion
|
Cohort 1: Placebo
n=1 Participants
Participants received placebo, with planned administration at Day 0 and Week 6 for a total of two infusions.
Participants continued their current non-study provided ART regimen.
Placebo: Diluent for REGN2810 , administered as an IV infusion
|
|---|---|---|
|
Count of Participants With a Grade >=1 irAE Related to Study Treatment
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline through Week 12Population: All participants
Change evaluated from baseline (average of pre-entry and entry measures) to post-baseline (average of weeks 2-12 measures). Results for each week are calculated by subtracting the corresponding background control value. If the result was less than zero after background subtraction, the result was set to zero.
Outcome measures
| Measure |
Cohort 1: Cemiplimab
n=4 Participants
Participants received 0.3 mg/kg of cemiplimab, with planned administration at Day 0 and Week 6 for a total of two infusions.
Participants continued their current non-study provided ART regimen.
Cemiplimab: Administered as an intravenous (IV) infusion
|
Cohort 1: Placebo
n=1 Participants
Participants received placebo, with planned administration at Day 0 and Week 6 for a total of two infusions.
Participants continued their current non-study provided ART regimen.
Placebo: Diluent for REGN2810 , administered as an IV infusion
|
|---|---|---|
|
Change in HIV-1 Gag-specific CD8+ T Cells by Intracellular Staining for CD107a and Interferon Gamma (IFNg) From Baseline to Post-baseline
|
0.01 Percentage of T cells
Standard Deviation 0.07
|
0.09 Percentage of T cells
Standard Deviation NA
No standard deviation due to N=1
|
SECONDARY outcome
Timeframe: Baseline through Week 12Population: All participants
Change evaluated from baseline (average of pre-entry and entry measures) to post-baseline (average of weeks 2-12 measures). Results for each week are calculated by subtracting the corresponding background control value. If the result was less than zero after background subtraction, the result was set to zero.
Outcome measures
| Measure |
Cohort 1: Cemiplimab
n=4 Participants
Participants received 0.3 mg/kg of cemiplimab, with planned administration at Day 0 and Week 6 for a total of two infusions.
Participants continued their current non-study provided ART regimen.
Cemiplimab: Administered as an intravenous (IV) infusion
|
Cohort 1: Placebo
n=1 Participants
Participants received placebo, with planned administration at Day 0 and Week 6 for a total of two infusions.
Participants continued their current non-study provided ART regimen.
Placebo: Diluent for REGN2810 , administered as an IV infusion
|
|---|---|---|
|
Change in HIV-1 Gag-specific CD8+ T Cells by Intracellular Staining for IFNg or CD107a Alone From Baseline to Post-baseline
|
0.00 Percentage of T cells
Standard Deviation 0.70
|
2.52 Percentage of T cells
Standard Deviation NA
No standard deviation due to N=1
|
SECONDARY outcome
Timeframe: Baseline through Week 12Population: All participants
Change evaluated from baseline (average of pre-entry and entry measures) to post-baseline (average of weeks 2-12 measures). Polyfunctional response was defined as being positive for two or more cytokines. Results for each week are calculated by subtracting the corresponding background control value. If the result was less than zero after background subtraction, the result was set to zero.
Outcome measures
| Measure |
Cohort 1: Cemiplimab
n=4 Participants
Participants received 0.3 mg/kg of cemiplimab, with planned administration at Day 0 and Week 6 for a total of two infusions.
Participants continued their current non-study provided ART regimen.
Cemiplimab: Administered as an intravenous (IV) infusion
|
Cohort 1: Placebo
n=1 Participants
Participants received placebo, with planned administration at Day 0 and Week 6 for a total of two infusions.
Participants continued their current non-study provided ART regimen.
Placebo: Diluent for REGN2810 , administered as an IV infusion
|
|---|---|---|
|
Change in Polyfunctional Response of HIV-1 Gag-specific CD8+ T Cells by Intracellular Staining for IFNg, CD107a, IL-2, and Tumor Necrosis Factor Alpha (TNFa) From Baseline to Post-baseline
|
0.24 Percentage of T cells
Standard Deviation 0.42
|
-0.86 Percentage of T cells
Standard Deviation NA
No standard deviation due to N=1
|
SECONDARY outcome
Timeframe: Baseline through Week 12Population: As per the analysis plan, only participants who received two study treatment infusions (at baseline and week 6) of the study treatment Cemiplimab are included (therefore the Placebo arm is not listed). The two participants with adverse events only received one infusion at baseline and are not included.
Change evaluated from baseline (average of pre-entry and entry measures) to after the first dose (average of Weeks 2-6), and from baseline to after the second dose (average of Weeks 8-12). Results for each week are calculated by subtracting the corresponding background control value. If the result was less than zero after background subtraction, the result was set to zero.
Outcome measures
| Measure |
Cohort 1: Cemiplimab
n=2 Participants
Participants received 0.3 mg/kg of cemiplimab, with planned administration at Day 0 and Week 6 for a total of two infusions.
Participants continued their current non-study provided ART regimen.
Cemiplimab: Administered as an intravenous (IV) infusion
|
Cohort 1: Placebo
Participants received placebo, with planned administration at Day 0 and Week 6 for a total of two infusions.
Participants continued their current non-study provided ART regimen.
Placebo: Diluent for REGN2810 , administered as an IV infusion
|
|---|---|---|
|
Change in HIV-1 Gag-specific CD8+ T Cells by Intracellular Staining for IFNg and CD107a After Each Infusion
After first dose
|
-0.01 Percentage of T cells
Standard Deviation 0.02
|
—
|
|
Change in HIV-1 Gag-specific CD8+ T Cells by Intracellular Staining for IFNg and CD107a After Each Infusion
After second dose
|
0.05 Percentage of T cells
Standard Deviation 0.20
|
—
|
Adverse Events
Cohort 1: Cemiplimab
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 1: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Cemiplimab
n=4 participants at risk
Participants received 0.3 mg/kg of cemiplimab, with planned administration at Day 0 and Week 6 for a total of two infusions.
Participants continued their current non-study provided ART regimen.
Cemiplimab: Administered as an intravenous (IV) infusion
|
Cohort 1: Placebo
n=1 participants at risk
Participants received placebo, with planned administration at Day 0 and Week 6 for a total of two infusions.
Participants continued their current non-study provided ART regimen.
Placebo: Diluent for REGN2810 , administered as an IV infusion
|
|---|---|---|
|
Endocrine disorders
Thyroiditis
|
25.0%
1/4 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
0.00%
0/1 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
25.0%
1/4 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
0.00%
0/1 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
|
Investigations
Thyroxine increased
|
25.0%
1/4 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
0.00%
0/1 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
Other adverse events
| Measure |
Cohort 1: Cemiplimab
n=4 participants at risk
Participants received 0.3 mg/kg of cemiplimab, with planned administration at Day 0 and Week 6 for a total of two infusions.
Participants continued their current non-study provided ART regimen.
Cemiplimab: Administered as an intravenous (IV) infusion
|
Cohort 1: Placebo
n=1 participants at risk
Participants received placebo, with planned administration at Day 0 and Week 6 for a total of two infusions.
Participants continued their current non-study provided ART regimen.
Placebo: Diluent for REGN2810 , administered as an IV infusion
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
25.0%
1/4 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
0.00%
0/1 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
|
General disorders
Fatigue
|
25.0%
1/4 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
0.00%
0/1 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
25.0%
1/4 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
0.00%
0/1 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
0.00%
0/1 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
25.0%
1/4 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
0.00%
0/1 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
2/4 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
100.0%
1/1 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
2/4 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
100.0%
1/1 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
|
Investigations
Blood bicarbonate decreased
|
25.0%
1/4 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
0.00%
0/1 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
|
Investigations
Blood creatinine increased
|
25.0%
1/4 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
0.00%
0/1 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/4 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
100.0%
1/1 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
|
Investigations
Blood pressure increased
|
25.0%
1/4 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
0.00%
0/1 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
25.0%
1/4 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
0.00%
0/1 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
|
Investigations
Blood uric acid increased
|
25.0%
1/4 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
0.00%
0/1 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
|
Investigations
Creatinine renal clearance decreased
|
25.0%
1/4 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
0.00%
0/1 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
|
Investigations
Neutrophil count decreased
|
25.0%
1/4 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
0.00%
0/1 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
|
Renal and urinary disorders
Proteinuria
|
50.0%
2/4 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
0.00%
0/1 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
0.00%
0/1 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
1/4 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
0.00%
0/1 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
50.0%
2/4 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
0.00%
0/1 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
25.0%
1/4 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
0.00%
0/1 • Study entry through week 48 or premature discontinuation.
AEs were defined as using the following criteria: All Grade ≥1 AEs, all suspected or confirmed irAEs, all infusion reactions, all AEs that led to a change in study intervention, all AEs meeting SAE definition or Expedited Adverse Event (EAE) reporting requirement, and all targeted events as specified in the protocol. The DAIDS AE Grading Table, V2.1 was used. Infusion reactions, adrenal insufficiency, and pneumonitis were graded by CTCAE guidelines, v5.0.
|
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, a DLH Holdings Company
Phone: (301) 628-3348
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights
- Publication restrictions are in place
Restriction type: OTHER