Trial Outcomes & Findings for Duvelisib in Combination With Nivolumab in Patients With Advanced Unresectable Melanoma (NCT NCT04688658)

Last Updated: 2025-12-17

Results Overview

Number of patients experiencing acute dose limiting toxicities (DLTs) and laboratory abnormalities considered possibly related to study treatment, occurring from the initial dose of duvelisib + nivolumab through day 28 of treatment (acute) or toxicities occurring from day 29 through 28 days after completion of treatment (late toxicities). DLTs are defined using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Up to 56 days (per patient)

Results posted on

2025-12-17

Participant Flow

No participants were enrolled in Phase 1: 25 mg BID Duvelisib and Phase II arms.

Participant milestones

Participant milestones
Measure	Duvelisib (15mg) + Nivolumab (240mg) Phase 1: Duvelisib,15mg once a day, 12 hours a part, to determine the recommended dose for the Phase II study when combined with nivolumab. Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor) Phase II: The Recommended Phase II dosage of duvelisib administered will not be determined until Phase I is completed. Nivolumab, 480mg, IV, every 4 weeks, for up to 1 year. Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) Phase 1: Duvelisib,25mg once a day, 12 hours a part, to determine the recommended dose for the Phase II study when combined with nivolumab. Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor)
Overall Study STARTED	7	6
Overall Study COMPLETED	7	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Duvelisib in Combination With Nivolumab in Patients With Advanced Unresectable Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Duvelisib (15mg) + Nivolumab (240mg) n=7 Participants Phase 1: Duvelisib,15mg once a day, 12 hours a part, to determine the recommended dose for the Phase II study when combined with nivolumab. Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor) Phase II: The Recommended Phase II dosage of duvelisib administered will not be determined until Phase I is completed. Nivolumab, 480mg, IV, every 4 weeks, for up to 1 year. Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=6 Participants Phase 1: Duvelisib,25mg once a day, 12 hours a part, to determine the recommended dose for the Phase II study when combined with nivolumab. Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor)	Total n=13 Participants Total of all reporting groups
Age, Continuous	66.00 years n=6 Participants	65.50 years n=5 Participants	66.00 years n=5 Participants
Sex: Female, Male Female	5 Participants n=6 Participants	3 Participants n=5 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=6 Participants	3 Participants n=5 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=6 Participants	6 Participants n=5 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=6 Participants	0 Participants n=5 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=6 Participants	6 Participants n=5 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=6 Participants	0 Participants n=5 Participants	1 Participants n=5 Participants
BRAF Status Mutant	2 Participants n=6 Participants	0 Participants n=5 Participants	2 Participants n=5 Participants
BRAF Status Wild Type (WT)	5 Participants n=6 Participants	6 Participants n=5 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 56 days (per patient)

Population: Treated patients evaluated for dose limiting toxicities.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=5 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=5 Participants Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
DLTs by Phase I Dose of Duvelisib With Nivolumab	0 participants	0 participants

PRIMARY outcome

Timeframe: Up to 29 months

Population: Patients who received at least one cycle of the treatment and at least one efficacy evaluation.

Best Response per RECIST v1.1: Completed Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10mm short axis); Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum diameters while on study. Progressive Disease (PD): ≥20% (relative) increase in sum of diameters of target lesions referencing smallest sum on study (includes baseline sum if is smallest on study) and, the sum must also demonstrate an absolute increase of at least 5 mm; appearance of one or more new lesions.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=5 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=4 Participants Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Best Overall Response Partial Response (PR)	1 Participants	0 Participants
Best Overall Response Stable Disease (SD)	1 Participants	1 Participants
Best Overall Response Progressive Disease (PD)	3 Participants	3 Participants

PRIMARY outcome

Timeframe: Up to 29 months

Population: Patients who received at least one cycle of the treatment and at least one efficacy evaluation.

Proportion of patients with a Best Response (CR+PR)/(CR+PR+SD+PD) per RECIST v1.1 of Completed Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10mm short axis); or Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=5 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=4 Participants Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Best Overall Response Rate (ORR)	0.20 proportion of patients Interval 0.0051 to 0.7164	0.0 proportion of patients Interval 0.0 to 0.6024

PRIMARY outcome

Timeframe: Baseline to Week 4

Population: Treated patients who provided samples for CD 8+ TIL testing.

CyTek flow cytometry will be used to evaluate tumor-infiltrating cells in PBMCs and tumor tissue for the increased frequency (proliferation) and activation of CD8+ TILs. Proliferation of CD8+ TIL cells correlate with improved survival in patients with melanoma.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=5 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=5 Participants Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Change in CD 8+ TIL Frequency Total CD8 T-cells (%CD45)	-0.87 percentage of cells Standard Deviation 2.91	2.66 percentage of cells Standard Deviation 3.65
Change in CD 8+ TIL Frequency Total Cycling CD8 (%Ki67+)	2.86 percentage of cells Standard Deviation 1.94	10.26 percentage of cells Standard Deviation 23.11
Change in CD 8+ TIL Frequency NAV. %CD8	-2.52 percentage of cells Standard Deviation 6.07	-1.44 percentage of cells Standard Deviation 6.61
Change in CD 8+ TIL Frequency TCM. %CD8	0.84 percentage of cells Standard Deviation 3.89	-0.22 percentage of cells Standard Deviation 5.13
Change in CD 8+ TIL Frequency TEM %CD8	2.92 percentage of cells Standard Deviation 4.60	1.46 percentage of cells Standard Deviation 4.98
Change in CD 8+ TIL Frequency TEMRA. %CD8	-1.25 percentage of cells Standard Deviation 1.94	-0.88 percentage of cells Standard Deviation 7.09

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: Treated patients who provided samples for CD 8+ TIL testing.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=5 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=5 Participants Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Change in CD 8+ TIL Frequency TCM. %CD8	-0.15 percentage of cells Standard Deviation 3.23	-8.91 percentage of cells Standard Deviation 3.41
Change in CD 8+ TIL Frequency TEM %CD8	7.97 percentage of cells Standard Deviation 6.60	6.60 percentage of cells Standard Deviation 6.65
Change in CD 8+ TIL Frequency Total CD8 T-cells (%CD45)	4.05 percentage of cells Standard Deviation 5.03	-1.63 percentage of cells Standard Deviation 3.58
Change in CD 8+ TIL Frequency Total Cycling CD8 (%Ki67+)	15.86 percentage of cells Standard Deviation 24.96	0.45 percentage of cells Standard Deviation 3.70
Change in CD 8+ TIL Frequency NAV. %CD8	-3.79 percentage of cells Standard Deviation 4.80	-1.68 percentage of cells Standard Deviation 2.37
Change in CD 8+ TIL Frequency TEMRA. %CD8	-4.06 percentage of cells Standard Deviation 8.10	4.00 percentage of cells Standard Deviation 0.85

PRIMARY outcome

Timeframe: Week 4 to Week 12

Population: Treated patients who provided samples for CD 8+ TIL testing.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=5 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=5 Participants Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Change in CD 8+ TIL Frequency TEMRA. %CD8	-3.62 percentage of cells Standard Deviation 6.62	8.20 percentage of cells Standard Deviation 5.37
Change in CD 8+ TIL Frequency Total CD8 T-cells (%CD45)	4.11 percentage of cells Standard Deviation 4.59	-2.69 percentage of cells Standard Deviation 0.69
Change in CD 8+ TIL Frequency Total Cycling CD8 (%Ki67+)	12.52 percentage of cells Standard Deviation 26.54	2.92 percentage of cells Standard Deviation 8.39
Change in CD 8+ TIL Frequency NAV. %CD8	1.44 percentage of cells Standard Deviation 2.19	-1.70 percentage of cells Standard Deviation 5.51
Change in CD 8+ TIL Frequency TCM. %CD8	-1.88 percentage of cells Standard Deviation 3.02	-13.26 percentage of cells Standard Deviation 6.73
Change in CD 8+ TIL Frequency TEM %CD8	4.03 percentage of cells Standard Deviation 5.85	6.75 percentage of cells Standard Deviation 6.86

SECONDARY outcome

Timeframe: At Week 12

Population: Patients who received at least one cycle of the treatment and at least one efficacy evaluation.

Complete response \[CR\], partial response \[PR\] or stable disease \[SD\], per RECIST v1.1 criteria . Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to \<10 mm. For non-target lesions: Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10mm short axis);PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD): ≥20% (relative) increase in sum of diameters of target lesions referencing smallest sum on study (includes baseline sum if is smallest on study) and, the sum must also demonstrate an absolute increase of at least 5 mm; appearance of one or more new lesions.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=5 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=4 Participants Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Clinical Benefit Partial Response (Week 12)	1 Participants	0 Participants
Clinical Benefit Stable Disease (Week 12)	0 Participants	1 Participants
Clinical Benefit Progressive Disease (Week 12)	4 Participants	3 Participants

SECONDARY outcome

Timeframe: At Week 24

Population: Patients who received at least one cycle of the treatment and at least one efficacy evaluation.

Complete response \[CR\], partial response \[PR\], stable disease \[SD\], per RECIST v1.1 criteria . Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to \<10 mm. For non-target lesions: Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10mm short axis);PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD): ≥20% (relative) increase in sum of diameters of target lesions referencing smallest sum on study (includes baseline sum if is smallest on study) and, the sum must also demonstrate an absolute increase of at least 5 mm; appearance of one or more new lesions.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=5 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=4 Participants Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Clinical Benefit	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At Week 48

Population: Patients who received at least one cycle of the treatment and at least one efficacy evaluation.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=5 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=4 Participants Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Clinical Benefit	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At Week 12

Population: Patients who received at least one cycle of the treatment and at least one efficacy evaluation.

Proportion of patients (CR + PR + SD)/(CR + PR + SD +PD) Complete response \[CR\], partial response \[PR\], stable disease \[SD\], per RECIST v1.1 criteria. Per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to \<10 mm. For non-target lesions: Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10mm short axis);PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD): ≥20% (relative) increase in sum of diameters of target lesions referencing smallest sum on study (includes baseline sum if is smallest on study) and, the sum must also demonstrate an absolute increase of at le

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=5 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=4 Participants Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Clinical Benefit Rate	0.20 proportion of patients Interval 0.0051 to 0.7164	0.25 proportion of patients Interval 0.0063 to 0.8059

SECONDARY outcome

Timeframe: Up to 4 weeks

Population: All treated patients.

Number and percentage of Acute adverse events as graded by CTCAE v5.0 in patients at each dosing interval and in the expansion cohort. Toxicity events include those that are possibly, probably or definitely related to study treatment per Criteria for Adverse Events version 5 (CTCAE v5.0).

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=7 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=6 Participants Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Acute Adverse Events at Least Possibly Related to Treatment Fever	0 Participants	1 Participants
Acute Adverse Events at Least Possibly Related to Treatment CD4 lymphocytes decreased	0 Participants	1 Participants
Acute Adverse Events at Least Possibly Related to Treatment Hyponatremia	1 Participants	0 Participants
Acute Adverse Events at Least Possibly Related to Treatment Myalgia	1 Participants	0 Participants
Acute Adverse Events at Least Possibly Related to Treatment Anemia	1 Participants	0 Participants
Acute Adverse Events at Least Possibly Related to Treatment Diarrhea	1 Participants	0 Participants
Acute Adverse Events at Least Possibly Related to Treatment Vomiting	0 Participants	1 Participants
Acute Adverse Events at Least Possibly Related to Treatment Chills	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Beginning at 4 weeks after start of treatment, up to 14 months

Population: All treated patients.

Number and percentage of Late occurring adverse events as graded by CTCAE v5.0 in patients at each dosing interval and in the expansion cohort. Toxicity events include those that are possibly, probably or definitely related to study treatment per Criteria for Adverse Events version 5 (CTCAE v5.0).

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=7 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=6 Participants Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Late Adverse Events at Least Possibly Related to Treatment Hyperthyroidism	2 Participants	0 Participants
Late Adverse Events at Least Possibly Related to Treatment Diarrhea	0 Participants	1 Participants
Late Adverse Events at Least Possibly Related to Treatment Vomiting	0 Participants	1 Participants
Late Adverse Events at Least Possibly Related to Treatment Hypothyroidism	0 Participants	1 Participants
Late Adverse Events at Least Possibly Related to Treatment Dry mouth	0 Participants	1 Participants
Late Adverse Events at Least Possibly Related to Treatment CD4 lymphocytes decreased	1 Participants	0 Participants
Late Adverse Events at Least Possibly Related to Treatment Fatigue	2 Participants	0 Participants
Late Adverse Events at Least Possibly Related to Treatment Hepatic failure	0 Participants	1 Participants
Late Adverse Events at Least Possibly Related to Treatment Alanine aminotransferase increased	3 Participants	3 Participants
Late Adverse Events at Least Possibly Related to Treatment Alkaline phosphatase increased	1 Participants	1 Participants
Late Adverse Events at Least Possibly Related to Treatment Aspartate aminotransferase increased	3 Participants	3 Participants
Late Adverse Events at Least Possibly Related to Treatment Blood bilirubin increased	0 Participants	1 Participants
Late Adverse Events at Least Possibly Related to Treatment Lymphocyte count decreased	0 Participants	1 Participants
Late Adverse Events at Least Possibly Related to Treatment Proteinuria	1 Participants	0 Participants
Late Adverse Events at Least Possibly Related to Treatment Hypertension	1 Participants	0 Participants
Late Adverse Events at Least Possibly Related to Treatment Neutrophil count decreased	0 Participants	1 Participants
Late Adverse Events at Least Possibly Related to Treatment White blood cell decreased	0 Participants	1 Participants
Late Adverse Events at Least Possibly Related to Treatment Anorexia	1 Participants	0 Participants
Late Adverse Events at Least Possibly Related to Treatment Generalized muscle weakness	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 42.5 months

Population: All treated patients.

Number of patients who experienced adverse events that are possibly, probably or definitely related to study treatment per Criteria for Adverse Events version 5 (CTCAE v5.0).

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=7 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=6 Participants Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Treatment Related Adverse Events	5 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to 42.5 months

Population: All treated patients.

Number of patients who experienced serious adverse events that are possibly, probably or definitely related to study treatment per Criteria for Adverse Events version 5 (CTCAE v5.0).

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=7 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=6 Participants Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Treatment Related Serious Adverse Events	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 42.5 months

Population: All treated patients.

Number of Patients with Treatment-related Grade 3 or Higher AE per CTCAE v5.0

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=7 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=6 Participants Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Treatment-related Grade 3 or Higher AE	4 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to 36 months

Population: Patients who received at least one cycle of the treatment and at least one efficacy evaluation.

Number of patients with Complete Response (CR) or Partial Response (PR) until the first time at which progressive disease is objectively documented per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to \<10 mm. For non-target lesions: Disappearance of all non-target lesions and normalization of tumormarker level. All lymph nodes must be non-pathological in size (\<10mm short axis);PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=5 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=4 Participants Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Number of Patients With Clinical Response	1 participants	0 participants

SECONDARY outcome

Timeframe: Up to 25 months

Population: Patients who received at least one cycle of the treatment and at least one efficacy evaluation. Among the 13 enrolled patients, 3 (2 in the 15 mg arm and 1 in the 25mg arm) were not evaluable as, per protocol, no duvelisib pills were returned for these patients.

The (median) length of time from the start of treatment that patients remain alive, until death from any cause. Patients who are alive will be censored at the time of the last follow-up.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=5 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=5 Participants Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Overall Survival (OS)	13.5 months Interval 12.2 to Upper bound of 95%CI not reached due small sample size and the rapidly decreasing number of patients at risk over time	4.9 months Interval 3.9 to Upper bound of 95%CI not reached due small sample size and the rapidly decreasing number of patients at risk over time

SECONDARY outcome

Timeframe: At 6 months

Population: Patients who received at least one cycle of the treatment and at least one efficacy evaluation.

The percentage of patients alive at 6 months the start of treatment until death from any cause.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=5 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=5 Participants Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
6-month Overall Survival (OS)	80.0 percentage of patients Interval 51.6 to 100.0	40.0 percentage of patients Interval 13.7 to 100.0

SECONDARY outcome

Timeframe: At 12 months

Population: Patients who received at least one cycle of the treatment and at least one efficacy evaluation.

The percentage of patients alive at 12 months the start of treatment until death from any cause.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=5 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=5 Participants Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
12-month Overall Survival (OS)	80.0 percentage of patients Interval 51.6 to 100.0	20.0 percentage of patients Interval 3.5 to 100.0

SECONDARY outcome

Timeframe: At 18 months

Population: Patients who received at least one cycle of the treatment and at least one efficacy evaluation.

The percentage of patients alive at 18 months the start of treatment until death from any cause.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=5 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=5 Participants Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
18-month Overall Survival (OS)	40.0 percentage of patients Interval 13.7 to 100.0	NA percentage of patients All patients either experience event or were censored before this timepoint

SECONDARY outcome

Timeframe: Up to 25 months

Population: Patients who received at least one cycle of the treatment and at least one efficacy evaluation.

The (median) length of time from the start of treatment that patients remain alive, until death from any cause. Patients who are alive will be censored at the time of the last follow-up.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=10 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Overall Survival (OS) - Total Population	9.9 months Interval 3.9 to Upper bound of 95% CI not reached due to limited number of events.	—

SECONDARY outcome

Timeframe: At 6 months

Population: Patients who received at least one cycle of the treatment and at least one efficacy evaluation.

The percentage of patients alive at 6 months the start of treatment until death from any cause.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=10 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
6-month Overall Survival (OS) - Total Population	60.0 percentage of patients Interval 36.2 to 99.5	—

SECONDARY outcome

Timeframe: At 12 months

Population: Patients who received at least one cycle of the treatment and at least one efficacy evaluation.

The percentage of patients alive at 12 months the start of treatment until death from any cause.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=10 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
12-month Overall Survival (OS) - Total Population	50.0 percentage of patients Interval 26.9 to 92.9	—

SECONDARY outcome

Timeframe: At 18 months

Population: Patients who received at least one cycle of the treatment and at least one efficacy evaluation.

The percentage of patients alive at 18 months the start of treatment until death from any cause.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=10 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
18-month Overall Survival (OS) -Total Population	30.0 percentage of patients Interval 11.6 to 77.3	—

SECONDARY outcome

Timeframe: Up to 36 months

Population: Patients who received at least one cycle of the treatment and at least one efficacy evaluation.

The (median) length of time from the initial date of treatment to the date of documented progression, or the date of death due to any cause (in the absence of progression, whichever occurs first), with progression defined by RECIST v1.1. PerRECIST v1.1, progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. For non-target lesions, PD: Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=5 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=5 Participants Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Progression-free Survival (PFS)	2.8 months Interval 2.8 to Upper bound of 95%CI not reached due to limited number of events	3.0 months Interval 2.8 to Upper bound of 95%CI not reached due to limited number of events

SECONDARY outcome

Timeframe: At 6 months

Population: Patients who received at least one cycle of the treatment and at least one efficacy evaluation.

The percentage of patients whose disease does not progress from initial date of treatment to at 6 months, with progression defined by RECIST v1.1. PerRECIST v1.1, progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. For non-target lesions, PD: Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=5 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=5 Participants Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
6-month Progression-free Survival (PFS)	20 percentage of participants Interval 3.5 to 100.0	0 percentage of participants At the 6-month timepoint, all patients on the 25mg dose experienced an event.

SECONDARY outcome

Timeframe: At 12 months

Population: Patients who received at least one cycle of the treatment and at least one efficacy evaluation.

The percentage of patients whose disease does not progress from initial date of treatment to at 12 months, with progression defined by RECIST v1.1. PerRECIST v1.1, progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. For non-target lesions, PD: Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=5 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=5 Participants Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
12-month Progression-free Survival (PFS)	0 percentage of participants At the 12-month timepoint, all patients on the experienced an event.	0 percentage of participants At the 12-month timepoint, all patients on the experienced an event.

SECONDARY outcome

Timeframe: At 18 months

Population: Patients who received at least one cycle of the treatment and at least one efficacy evaluation.

The percentage of patients whose disease does not progress from initial date of treatment to at 18 months, with progression defined by RECIST v1.1. PerRECIST v1.1, progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. For non-target lesions, PD: Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=5 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=5 Participants Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
18-month Progression-free Survival (PFS)	0 percentage of participants At the 18-month timepoint, all patients experienced an event.	0 percentage of participants At the 18-month timepoint, all patients experienced an event.

SECONDARY outcome

Timeframe: Up to 36 months

Population: Patients who received at least one cycle of the treatment and at least one efficacy evaluation.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=10 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Progression-free Survival (PFS) - Total Population	2.8 months Interval 2.6 to Upper bound of 95% CI not reached due to limited number of events.	—

SECONDARY outcome

Timeframe: At 6 months

Population: Patients who received at least one cycle of the treatment and at least one efficacy evaluation.

The percentage of patients whose disease does not progress from initial date of treatment to at 6 months, with progression defined by RECIST v1.1. Per RECIST v1.1, progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. For non-target lesions, PD: Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=10 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
6-month Progression-free Survival (PFS) - Total Population	10.0 percentage of patients Interval 1.6 to 64.2	—

SECONDARY outcome

Timeframe: At 12 months

Population: Patients who received at least one cycle of the treatment and at least one efficacy evaluation.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=10 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
12-month Progression-free Survival (PFS) - Total Population	0 percentage of patients At the 12-month timepoint, all patients from both dose levels had experienced progression or death before this timepoint; therefore, no patients remained progression-free at 12 months.	—

SECONDARY outcome

Timeframe: At 18 months

Population: Treated patients who were radiologically evaluable.

Outcome measures

Outcome measures
Measure	Duvelisib (15mg and 25mg) + Nivolumab (240mg) n=10 Participants Duvelisib,15mg or 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to one year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) Duvelisib, 25mg once a day, 12 hours a part Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor for up to 1 year) Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
18-month Progression-free Survival (PFS) - Total Population	0 percentage of participants At the 18-month timepoint, all patients from both dose levels had experienced progression or death before this timepoint; therefore, no patients remained progression-free at 18 months.	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (prior to treatment), at 12 weeks after start of treatment; Up to 2 years (cohort)

Other events: 6 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

Barbara Stadterman, MPH, CCRP

UPMC Hillman Cancer Center

Phone: 4126475554

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Duvelisib (15mg) + Nivolumab (240mg) n=7 participants at risk Phase 1: Duvelisib,15mg once a day, 12 hours a part, to determine the recommended dose for the Phase II study when combined with nivolumab. Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor) Phase II: The Recommended Phase II dosage of duvelisib administered will not be determined until Phase I is completed. Nivolumab, 480mg, IV, every 4 weeks, for up to 1 year. Nivolumab: Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer. Duvelisib: Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	Duvelisib (25mg) + Nivolumab (240mg) n=6 participants at risk Phase 1: Duvelisib, 25mg once a day, 12 hours a part, to determine the recommended dose for the Phase II study when combined with nivolumab. Nivolumab, 240mg, IV, every 2 weeks for the first four cycles; thereafter it may be switched to 480mg, IV, once every 4 weeks (if deemed appropriate by the study doctor)
GASTROINTESTINAL DISORDERS Retroperitoneal hemorrhage	14.3% 1/7 • Adverse events data collected for up to 42.5 months for the study population.	0.00% 0/6 • Adverse events data collected for up to 42.5 months for the study population.
GASTROINTESTINAL DISORDERS Vomiting	14.3% 1/7 • Adverse events data collected for up to 42.5 months for the study population.	0.00% 0/6 • Adverse events data collected for up to 42.5 months for the study population.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Death NOS	28.6% 2/7 • Adverse events data collected for up to 42.5 months for the study population.	0.00% 0/6 • Adverse events data collected for up to 42.5 months for the study population.
HEPATOBILIARY DISORDERS Hepatic failure	14.3% 1/7 • Adverse events data collected for up to 42.5 months for the study population.	0.00% 0/6 • Adverse events data collected for up to 42.5 months for the study population.
INFECTIONS AND INFESTATIONS Covid	14.3% 1/7 • Adverse events data collected for up to 42.5 months for the study population.	0.00% 0/6 • Adverse events data collected for up to 42.5 months for the study population.
INFECTIONS AND INFESTATIONS Lung infection	0.00% 0/7 • Adverse events data collected for up to 42.5 months for the study population.	16.7% 1/6 • Adverse events data collected for up to 42.5 months for the study population.
INFECTIONS AND INFESTATIONS Sepsis	0.00% 0/7 • Adverse events data collected for up to 42.5 months for the study population.	16.7% 1/6 • Adverse events data collected for up to 42.5 months for the study population.
INVESTIGATIONS Alanine aminotransferase increased	28.6% 2/7 • Adverse events data collected for up to 42.5 months for the study population.	16.7% 1/6 • Adverse events data collected for up to 42.5 months for the study population.
INVESTIGATIONS Aspartate aminotransferase increased	28.6% 2/7 • Adverse events data collected for up to 42.5 months for the study population.	16.7% 1/6 • Adverse events data collected for up to 42.5 months for the study population.
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) Neoplasms benign, malignant and unspecified (incl cysts and polyps) -Other, specifyBrain \|Neoplasm	0.00% 0/7 • Adverse events data collected for up to 42.5 months for the study population.	16.7% 1/6 • Adverse events data collected for up to 42.5 months for the study population.
NERVOUS SYSTEM DISORDERS Edema cerebral	0.00% 0/7 • Adverse events data collected for up to 42.5 months for the study population.	16.7% 1/6 • Adverse events data collected for up to 42.5 months for the study population.
NERVOUS SYSTEM DISORDERS Encephalopathy	0.00% 0/7 • Adverse events data collected for up to 42.5 months for the study population.	16.7% 1/6 • Adverse events data collected for up to 42.5 months for the study population.
NERVOUS SYSTEM DISORDERS Lethargy	0.00% 0/7 • Adverse events data collected for up to 42.5 months for the study population.	16.7% 1/6 • Adverse events data collected for up to 42.5 months for the study population.
NERVOUS SYSTEM DISORDERS Seizure	0.00% 0/7 • Adverse events data collected for up to 42.5 months for the study population.	16.7% 1/6 • Adverse events data collected for up to 42.5 months for the study population.
PSYCHIATRIC DISORDERS Confusion	0.00% 0/7 • Adverse events data collected for up to 42.5 months for the study population.	33.3% 2/6 • Adverse events data collected for up to 42.5 months for the study population.
RENAL AND URINARY DISORDERS Acute kidney injury	14.3% 1/7 • Adverse events data collected for up to 42.5 months for the study population.	0.00% 0/6 • Adverse events data collected for up to 42.5 months for the study population.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Respiratory failure	14.3% 1/7 • Adverse events data collected for up to 42.5 months for the study population.	0.00% 0/6 • Adverse events data collected for up to 42.5 months for the study population.
SURGICAL AND MEDICAL PROCEDURES sternectomy with reconstruction	14.3% 1/7 • Adverse events data collected for up to 42.5 months for the study population.	0.00% 0/6 • Adverse events data collected for up to 42.5 months for the study population.
CARDIAC DISORDERS Atrial fibrillation	14.3% 1/7 • Adverse events data collected for up to 42.5 months for the study population.	0.00% 0/6 • Adverse events data collected for up to 42.5 months for the study population.
GASTROINTESTINAL DISORDERS Diarrhea	14.3% 1/7 • Adverse events data collected for up to 42.5 months for the study population.	0.00% 0/6 • Adverse events data collected for up to 42.5 months for the study population.