Trial Outcomes & Findings for Gemcitabine, Bendamustine, and Nivolumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (NCT NCT03739619)

NCT ID: NCT03739619

Last Updated: 2025-08-06

Results Overview

Maximum tolerable dose will be defined as the highest dose level where at most 1 of 6 patients experience dose limiting toxicity (DLT).

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: Up to completion of course 2 at 42 days after study start
• Results posted on: 2025-08-06

Participant Flow

Participant milestones

Measure	Gemcitabine, Bendamustine, Nivolumab Patients receive gemcitabine IV over 30 minutes on day 1, bendamustine IV over 30 minutes on days 1 and 2, and nivolumab over 60 minutes IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then receive nivolumab IV over 60 minutes on day 1. Treatment with single agent nivolumab repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Bendamustine: Given IV Gemcitabine: Given IV Nivolumab: Given IV
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gemcitabine, Bendamustine, and Nivolumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

Baseline characteristics by cohort

Measure	Gemcitabine, Bendamustine, Nivolumab n=3 Participants Patients receive gemcitabine IV over 30 minutes on day 1, bendamustine IV over 30 minutes on days 1 and 2, and nivolumab over 60 minutes IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then receive nivolumab IV over 60 minutes on day 1. Treatment with single agent nivolumab repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Bendamustine: Given IV Gemcitabine: Given IV Nivolumab: Given IV
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=93 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants
Race (NIH/OMB) White	1 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	3 participants n=93 Participants

PRIMARY outcome

Timeframe: Up to completion of course 2 at 42 days after study start

Population: The median values were not reached. No MTD events were observed within the trial time frame; thus, median MTD were not reached.

Maximum tolerable dose will be defined as the highest dose level where at most 1 of 6 patients experience dose limiting toxicity (DLT).

Outcome measures

Measure

Gemcitabine, Bendamustine, Nivolumab n=3 Participants Patients receive gemcitabine IV over 30 minutes on day 1, bendamustine IV over 30 minutes on days 1 and 2, and nivolumab over 60 minutes IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then receive nivolumab IV over 60 minutes on day 1. Treatment with single agent nivolumab repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Bendamustine: Given IV Gemcitabine: Given IV Nivolumab: Given IV

Maximum Tolerable Dose (Phase I)

NA Participants The median values were not reached. No MTD events were observed within the trial time frame; thus, median MTD were not reached.

PRIMARY outcome

Timeframe: Up to 2 years from discontinuation of study therapy

Complete response rate will be determined by dividing the number of CRs (per Lugano criteria) by the total number of evaluable patients.

Outcome measures

Measure

Gemcitabine, Bendamustine, Nivolumab n=2 Participants Patients receive gemcitabine IV over 30 minutes on day 1, bendamustine IV over 30 minutes on days 1 and 2, and nivolumab over 60 minutes IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then receive nivolumab IV over 60 minutes on day 1. Treatment with single agent nivolumab repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Bendamustine: Given IV Gemcitabine: Given IV Nivolumab: Given IV

Complete Response (CR) Rate (Phase II)

1 Participants

SECONDARY outcome

Timeframe: Up to 2 years from discontinuation of study therapy

Overall response rate will be evaluated using Lugano criteria of response. Overall response rate will be defined as the total number of patients achieving a partial response or CR as best response through cycle 6 divided by total number of patients treated.

Outcome measures

Measure

Gemcitabine, Bendamustine, Nivolumab n=2 Participants Patients receive gemcitabine IV over 30 minutes on day 1, bendamustine IV over 30 minutes on days 1 and 2, and nivolumab over 60 minutes IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then receive nivolumab IV over 60 minutes on day 1. Treatment with single agent nivolumab repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Bendamustine: Given IV Gemcitabine: Given IV Nivolumab: Given IV

Overall Response Rate (Phase II)

1 Participants

SECONDARY outcome

Timeframe: Up to 2 years from discontinuation of study therapy

Duration of response will be evaluated using Lugano criteria of response and will be determined from date of best response to progression or death.

Outcome measures

Measure

Gemcitabine, Bendamustine, Nivolumab n=1 Participants Patients receive gemcitabine IV over 30 minutes on day 1, bendamustine IV over 30 minutes on days 1 and 2, and nivolumab over 60 minutes IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then receive nivolumab IV over 60 minutes on day 1. Treatment with single agent nivolumab repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Bendamustine: Given IV Gemcitabine: Given IV Nivolumab: Given IV

Duration of Response (Phase II)

892 Days

SECONDARY outcome

Timeframe: Up to 2 years from discontinuation of study therapy

Progression free survival will be evaluated using Lugano criteria and will be determined from date of first dose of study drug to progression or death.

Outcome measures

Measure

Gemcitabine, Bendamustine, Nivolumab n=3 Participants Patients receive gemcitabine IV over 30 minutes on day 1, bendamustine IV over 30 minutes on days 1 and 2, and nivolumab over 60 minutes IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then receive nivolumab IV over 60 minutes on day 1. Treatment with single agent nivolumab repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Bendamustine: Given IV Gemcitabine: Given IV Nivolumab: Given IV

Progression Free Survival (PFS) (Phase II)

NA months Too few events for a median to be reached. @ Timepoint 1.0 (NA,NA - not computable as no patient received an event) The median values were not reached. No PFS events were observed within the trial time frame; thus, median PFS were not reached.

SECONDARY outcome

Timeframe: Up to 2 years from discontinuation of study therapy

Overall survival will be evaluated using Lugano criteria and will be determined from date of first dose of study drug to death from any cause.

Outcome measures

Measure

Gemcitabine, Bendamustine, Nivolumab n=3 Participants Patients receive gemcitabine IV over 30 minutes on day 1, bendamustine IV over 30 minutes on days 1 and 2, and nivolumab over 60 minutes IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then receive nivolumab IV over 60 minutes on day 1. Treatment with single agent nivolumab repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Bendamustine: Given IV Gemcitabine: Given IV Nivolumab: Given IV

Overall Survival (OS) (Phase II)

NA months The median values were not reached. No OS events were observed within the trial time frame; thus, median OS were not reached.

Adverse Events

Gemcitabine, Bendamustine, Nivolumab

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure

Gemcitabine, Bendamustine, Nivolumab n=3 participants at risk Patients receive gemcitabine IV over 30 minutes on day 1, bendamustine IV over 30 minutes on days 1 and 2, and nivolumab over 60 minutes IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then receive nivolumab IV over 60 minutes on day 1. Treatment with single agent nivolumab repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Bendamustine: Given IV Gemcitabine: Given IV Nivolumab: Given IV

Respiratory, thoracic and mediastinal disorders Hospitalization

66.7% 2/3 • Number of events 2 • Adverse Events monitored/assessed up to 2 years. All-Cause Mortality monitored/assessed up to 2 years from discontinuation of study therapy a maximum of 4 years

Other adverse events

Measure	Gemcitabine, Bendamustine, Nivolumab n=3 participants at risk Patients receive gemcitabine IV over 30 minutes on day 1, bendamustine IV over 30 minutes on days 1 and 2, and nivolumab over 60 minutes IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then receive nivolumab IV over 60 minutes on day 1. Treatment with single agent nivolumab repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Bendamustine: Given IV Gemcitabine: Given IV Nivolumab: Given IV
Blood and lymphatic system disorders Anemia	33.3% 1/3 • Number of events 5 • Adverse Events monitored/assessed up to 2 years. All-Cause Mortality monitored/assessed up to 2 years from discontinuation of study therapy a maximum of 4 years
Investigations Decreased Platelet Count	33.3% 1/3 • Number of events 3 • Adverse Events monitored/assessed up to 2 years. All-Cause Mortality monitored/assessed up to 2 years from discontinuation of study therapy a maximum of 4 years
Nervous system disorders Headache	66.7% 2/3 • Number of events 3 • Adverse Events monitored/assessed up to 2 years. All-Cause Mortality monitored/assessed up to 2 years from discontinuation of study therapy a maximum of 4 years
Vascular disorders Hypertension	33.3% 1/3 • Number of events 7 • Adverse Events monitored/assessed up to 2 years. All-Cause Mortality monitored/assessed up to 2 years from discontinuation of study therapy a maximum of 4 years
Metabolism and nutrition disorders Hypokalemia	33.3% 1/3 • Number of events 3 • Adverse Events monitored/assessed up to 2 years. All-Cause Mortality monitored/assessed up to 2 years from discontinuation of study therapy a maximum of 4 years
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 7 • Adverse Events monitored/assessed up to 2 years. All-Cause Mortality monitored/assessed up to 2 years from discontinuation of study therapy a maximum of 4 years

Additional Information

Jonathon Cohen, MD

Emory University

Phone: 404-778-2214

Email: jonathon.cohen@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place