Trial Outcomes & Findings for Durvalumab (MEDI4736) and Tremelimumab for Hepatocellular Carcinoma in Patients Listed for a Liver Transplant (NCT NCT05027425)

Last Updated: 2026-05-06

Results Overview

To assess the safety of immunotherapy for treatment of HCC in patients listed for a liver transplant, with respect to cellular rejection rates

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Up to 30 days post transplant. The average time from consent to transplant was 11.88 months.

Results posted on

2026-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	Durvalumab + Tremelimumab + Liver Transplant Patients will be treated with the immunotherapy combination for up to 4 months. After a minimum 28 day washout, they will undergo locoregional therapy per institutional standards. Eventually, after a minimum 72-day washout from the end of immunotherapy, they will undergo liver transplant. Durvalumab: 1500 mg IV, Q4W Tremelimumab: 300 mg IV, 1 dose on day 1 of only the first cycle Liver Transplant: minimum 72-day washout from the end of immunotherapy, patients will undergo liver transplant.
Prior to Liver Transplant STARTED	8
Prior to Liver Transplant COMPLETED	5
Prior to Liver Transplant NOT COMPLETED	3
Received Transplant STARTED	5
Received Transplant COMPLETED	5
Received Transplant NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Durvalumab (MEDI4736) and Tremelimumab for Hepatocellular Carcinoma in Patients Listed for a Liver Transplant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Durvalumab + Tremelimumab + Liver Transplant n=8 Participants Patients will be treated with the immunotherapy combination for up to 4 months. After a minimum 28 day washout, they will undergo locoregional therapy per institutional standards. Eventually, after a minimum 72-day washout from the end of immunotherapy, they will undergo liver transplant. Durvalumab: 1500 mg IV, Q4W Tremelimumab: 300 mg IV, 1 dose on day 1 of only the first cycle Liver Transplant: minimum 72-day washout from the end of immunotherapy, patients will undergo liver transplant.
Age, Continuous	68 years n=54 Participants
Sex: Female, Male Female	3 Participants n=54 Participants
Age, Categorical <=18 years	0 Participants n=54 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=54 Participants
Age, Categorical >=65 years	5 Participants n=54 Participants
Sex: Female, Male Male	5 Participants n=54 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=54 Participants
Race (NIH/OMB) Asian	0 Participants n=54 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=54 Participants
Race (NIH/OMB) Black or African American	1 Participants n=54 Participants
Race (NIH/OMB) White	7 Participants n=54 Participants
Race (NIH/OMB) More than one race	0 Participants n=54 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=54 Participants
Region of Enrollment United States	8 participants n=54 Participants

PRIMARY outcome

Timeframe: Up to 30 days post transplant. The average time from consent to transplant was 11.88 months.

Population: 8 subjects were enrolled but only 5 received a liver transplant.

To assess the safety of immunotherapy for treatment of HCC in patients listed for a liver transplant, with respect to cellular rejection rates

Outcome measures

Outcome measures
Measure	Participants That Received a Liver Transplant n=5 Participants 8 subjects were enrolled but only 5 received a liver transplant.
Cellular Rejection Rates	0 Participants

SECONDARY outcome

Timeframe: Adverse events will be collected from study drug initiation until 90 days after the last durvalumab+tremelimumab dose or before new anti-cancer therapy, whichever comes first, up to 7 months.

Population: 8 subjects were enrolled but only 5 received a liver transplant.

To assess the safety of immunotherapy for treatment of HCC in patients who have received a transplant, with respect to adverse events during treatment.

Outcome measures

Outcome measures
Measure	Participants That Received a Liver Transplant n=5 Participants 8 subjects were enrolled but only 5 received a liver transplant.
Adverse Events During Treatment	5 Participants

SECONDARY outcome

Timeframe: Timeframe includes 4 months of I/0 treatment. Radiologic responses were measured after the I/O treatment phase of the study

Population: Individuals who completed 28 days I/O treatment will be assessed radiologically.

To assess the efficacy of immunotherapy for treatment of HCC in patients listed for a liver transplant, with respect to radiologic responses. This will be be defined the number of individuals that had complete response, partial response, or stable disease. Progressive disease will not be included. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Participants That Received a Liver Transplant n=8 Participants 8 subjects were enrolled but only 5 received a liver transplant.
Radiologic Responses Via RECIST 1.1 and/or mRECIST	8 Participants

SECONDARY outcome

Timeframe: Timeframe includes the 30 day window after a transplant.

Population: However, due to the feasibility of the trial, we were not able to collect data for this outcome.

To assess the efficacy of immunotherapy for treatment of HCC in patients listed for a liver transplant, with respect to Pathologic responses. However, due to the feasibility of the trial, we were not able to collect data for this outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Survival follow up will continue for 5 years after end of Treatment

Population: However, due to the feasibility of the trial, we were not able to collect data for this outcome.

To assess the efficacy of immunotherapy for treatment of HCC in patients listed for a liver transplant, with respect to Survival outcomes. However, due to the feasibility of the trial, we were not able to collect data for this outcome.

Outcome measures

Outcome measures
Measure	Participants That Received a Liver Transplant 8 subjects were enrolled but only 5 received a liver transplant.
Recurrence-free Survival and Overall Survival Outcomes Based on Survival Follow up Reporting	0 Participants

SECONDARY outcome

Timeframe: Day 72 post completion of immunotherapy, approximately 6.5 months

Population: The data reflects the number of graft loss from those who received a transplant.

To assess the safety of immunotherapy for treatment of HCC in patients listed for a liver transplant, with respect graft loss

Outcome measures

Outcome measures
Measure	Participants That Received a Liver Transplant n=5 Participants 8 subjects were enrolled but only 5 received a liver transplant.
Graft Loss	0 Participants

SECONDARY outcome

Timeframe: Day 72 post completion of immunotherapy, approximately 7.5 months.

To assess the safety of immunotherapy for treatment of HCC in patients listed for a liver transplant, with respect to mortality rates up to 30 days after transplant

Outcome measures

Outcome measures
Measure	Participants That Received a Liver Transplant n=5 Participants 8 subjects were enrolled but only 5 received a liver transplant.
Mortality	0 Participants

Adverse Events

Durvalumab + Tremelimumab + Liver Transplant

Serious events: 5 serious events

Other events: 8 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Durvalumab + Tremelimumab + Liver Transplant n=8 participants at risk Patients will be treated with the immunotherapy combination for up to 4 months. After a minimum 28 day washout, they will undergo locoregional therapy per institutional standards. Eventually, after a minimum 72-day washout from the end of immunotherapy, they will undergo liver transplant. Durvalumab: 1500 mg IV, Q4W Tremelimumab: 300 mg IV, 1 dose on day 1 of only the first cycle Liver Transplant: minimum 72-day washout from the end of immunotherapy, patients will undergo liver transplant.
Investigations Alanine aminotransferase increased	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Investigations Aspartate aminotransferase increased	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Gastrointestinal disorders Colitis	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Metabolism and nutrition disorders Dehydration	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ductal carcinoma in-situ	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Gastrointestinal disorders Pan colitis	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Hepatobiliary disorders Hepatic artery thrombosis	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Infections and infestations Lung infection	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.

Other adverse events

Other adverse events
Measure	Durvalumab + Tremelimumab + Liver Transplant n=8 participants at risk Patients will be treated with the immunotherapy combination for up to 4 months. After a minimum 28 day washout, they will undergo locoregional therapy per institutional standards. Eventually, after a minimum 72-day washout from the end of immunotherapy, they will undergo liver transplant. Durvalumab: 1500 mg IV, Q4W Tremelimumab: 300 mg IV, 1 dose on day 1 of only the first cycle Liver Transplant: minimum 72-day washout from the end of immunotherapy, patients will undergo liver transplant.
Gastrointestinal disorders Abdominal distension	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Gastrointestinal disorders Abdominal pain	62.5% 5/8 • Number of events 6 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Investigations Alanine aminotransferase increased	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Skin and subcutaneous tissue disorders Angioma	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Metabolism and nutrition disorders Anorexia	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 2/8 • Number of events 3 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Investigations Aspartate aminotransferase increased	25.0% 2/8 • Number of events 2 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Musculoskeletal and connective tissue disorders Back pain	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Gastrointestinal disorders Bloating	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Investigations Blood bilirubin increased	25.0% 2/8 • Number of events 2 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Nervous system disorders Brain fog	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Cardiac disorders Tachycardia	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Nervous system disorders Concentration impairment	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Psychiatric disorders Confusion	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Infections and infestations Conjunctivitis	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Gastrointestinal disorders Constipation	37.5% 3/8 • Number of events 3 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 2/8 • Number of events 2 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Infections and infestations COVID-19	25.0% 2/8 • Number of events 2 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Investigations Creatinine increased	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Gastrointestinal disorders Dentin hypersensitivity	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Gastrointestinal disorders Diarrhea	62.5% 5/8 • Number of events 6 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Nervous system disorders Dizziness	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Gastrointestinal disorders Dry mouth	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Gastrointestinal disorders Dysphasia	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Respiratory, thoracic and mediastinal disorders Dyspnea	25.0% 2/8 • Number of events 2 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
General disorders Edema limbs	25.0% 2/8 • Number of events 2 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Respiratory, thoracic and mediastinal disorders Epistaxis	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Skin and subcutaneous tissue disorders Erythema	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
General disorders Fatigue	75.0% 6/8 • Number of events 7 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
General disorders Fever	50.0% 4/8 • Number of events 6 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Musculoskeletal and connective tissue disorders Flank pain	25.0% 2/8 • Number of events 2 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
General disorders Flu like symptoms	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Musculoskeletal and connective tissue disorders Generalized weakness	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Hepatobiliary disorders Hepatic pain	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Vascular disorders Hot flashes	25.0% 2/8 • Number of events 2 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Metabolism and nutrition disorders Hypermagnesemia	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Metabolism and nutrition disorders Hyperphosphatemia	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Vascular disorders Hypertension	25.0% 2/8 • Number of events 2 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Endocrine disorders Hyperthyroidism	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Metabolism and nutrition disorders Hypokalemia	12.5% 1/8 • Number of events 5 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Endocrine disorders Hypothyroidism	25.0% 2/8 • Number of events 2 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Injury, poisoning and procedural complications Infusion related reaction	12.5% 1/8 • Number of events 5 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Psychiatric disorders Insomnia	25.0% 2/8 • Number of events 2 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Musculoskeletal and connective tissue disorders Joint pain	25.0% 2/8 • Number of events 2 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Nervous system disorders Lethargy	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Nervous system disorders Lightheadedness	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Investigations Lipase increased	37.5% 3/8 • Number of events 3 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Musculoskeletal and connective tissue disorders Myalgia	37.5% 3/8 • Number of events 3 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Gastrointestinal disorders Nausea	50.0% 4/8 • Number of events 6 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Reproductive system and breast disorders Nipple pain	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Renal and urinary disorders Nocturia	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Cardiac disorders Palpitations	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Gastrointestinal disorders Pancreatitis	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Eye disorders Photophobia	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Respiratory, thoracic and mediastinal disorders Productive cough	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Skin and subcutaneous tissue disorders Pruritus	25.0% 2/8 • Number of events 2 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Investigations Serum amylase increased	12.5% 1/8 • Number of events 2 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Injury, poisoning and procedural complications Tooth fracture	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Renal and urinary disorders Urinary frequency	25.0% 2/8 • Number of events 2 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Renal and urinary disorders Urinary urgency	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Gastrointestinal disorders Vomiting	37.5% 3/8 • Number of events 3 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Investigations Weight gain	25.0% 2/8 • Number of events 3 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Investigations Weight loss	50.0% 4/8 • Number of events 7 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.
Investigations White blood cell decreased	12.5% 1/8 • Number of events 1 • Deaths, Serious Adverse Events (SAEs) and Adverse Events will be collected from the initiation of study drug and for 90 days after the last dose of durvalumab+tremelimumab or before initiation of a new anti-cancer therapy Definitions do not differ from clinicaltrials.gov.

Additional Information

Dr. Davendra Sohal

University of Cincinnati Cancer Center

Phone: +1 513 558 2361

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place