Tremelimumab

CTLA-4 is a negative regulator of T-cell activity. Tremelimumab-actl is a monoclonal antibody that binds to CTLA-4 and blocks the interaction with its ligands CD80 and CD86, releasing CTLA-4-mediated inhibition of T-cell activation.

• IMJUDO is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated: • in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). ( 1.1 ) • in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.ICD-10: C34.90, C85.90

• None. None.contraindicated

• Administer IMJUDO as an intravenous infusion over 60 minutes after dilution. ( 2.3 ) • uHCC: Weight 30 kg and more: IMJUDO 300 mg as a single dose in combination with durvalumab 1,500 mg at Cycle 1/Day 1, followed by durvalumab as a single agent every 4 weeks ( 2.1 ) Weight less than 30 kg: IMJUDO 4 mg/kg as a single dose in combination with durvalumab 20 mg/kg at Cycle 1/Day 1, followed by durvalumab as a single agent every 4 weeks ( 2.1 ) • Metastatic NSCLC: Weight 30 kg and more: 75 mg every 3 weeks in combination with durvalumab 1,500 mg and platinum-based chemotherapy for 4 cycles, and then administer durvalumab 1,500 mg every 4 weeks as a single agent with histology-based pemetrexed therapy every 4 weeks, and a fifth dose of IMJUDO 75 mg in combination with durvalumab dose 6 at week 16 ( 2.1 ) Weight less than 30 kg: 1 mg/kg every 3 weeks in combination with durvalumab 20 mg/kg and platinum-based chemotherapy for 4 cycles, and then administer durvalumab 20 mg/kg every 4 weeks as a single agent with histology-based pemetrexed therapy every 4 weeks, and a fifth dose of IMJUDO 1 mg/kg in combination with durvalumab dose 6 at week 16 ( 2.1 ) • See full Prescribing Information for preparation and administration instructions and dosage modifications for adverse reactions. 2.1 Recommended Dosage The recommended dosages of IMJUDO are presented in Tables 1, 2 and 3. Administer IMJUDO as an intravenous infusion after dilution as recommended [see Dosage and Administration (2.3) ]. IMJUDO in Combination with Durvalumab Table 1.

• Immune-Mediated Adverse Reactions ( 5.1 ) Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis with renal dysfunction, immune-mediated dermatologic adverse reactions and immune-mediated pancreatitis. o Monitor for early identification and management. Evaluate liver enzymes, creatinine, adrenocorticotropic hormone level and thyroid function at baseline and before each dose. o Withhold or permanently discontinue based on severity and type of reaction. • Infusion-Related Reactions: Interrupt, slow the rate of infusion, or permanently discontinue treatment based on the severity of the reaction. ( 5.2 ) • Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception. ( 5.3 , 8.1 , 8.3 ) 5.1 Severe and Fatal Immune-Mediated Adverse Reactions IMJUDO is a monoclonal antibody that blocks T-cell inhibitory signals induced by the CTLA-4 pathway, thereby removing inhibition of the immune response. In combination with durvalumab, a PD-L1 inhibitor, these drugs have the potential for induction of immune-mediated adverse reactions. Immune-mediated adverse reactions listed herein may not be inclusive of all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue.

The following adverse reactions are discussed in greater detail in other sections of the labeling. • Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1) ] . • Infusion-Related Reactions [see Warnings and Precautions (5.2) ]. Most common adverse reactions (≥ 20%) of patients with uHCC are rash, diarrhea, fatigue, pruritus, musculoskeletal pain, and abdominal pain. Most common laboratory abnormalities (≥ 40%) of patients with uHCC are AST increased, ALT increased, hemoglobin decreased, sodium decreased, bilirubin increased, alkaline phosphatase increased, and lymphocytes decreased. ( 6.1 ) Most common adverse reactions (≥ 20%) of patients with metastatic NSCLC were nausea, fatigue, musculoskeletal pain, decreased appetite, rash, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described in the Warnings and Precautions reflect exposure to IMJUDO 300 mg in combination with durvalumab 1,500 mg in 388 patients in HIMALAYA. In the HIMALAYA study patients received IMJUDO 300 mg administered as a single intravenous infusion in combination with durvalumab 1,500 mg on the same day, followed by durvalumab every 4 weeks.

Lactation: Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk summary Based on findings from animal studies and its mechanism of action, IMJUDO can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of IMJUDO in pregnant women. In animal studies, CTLA-4 blockade is associated with increased risk of immune-mediated rejection of the developing fetus and fetal death ( see Data ). Human immunoglobulin G2 (IgG2) is known to cross the placental barrier; therefore, IMJUDO has the potential to be transmitted from the mother to the developing fetus. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In a reproduction study, administration of tremelimumab-actl to pregnant cynomolgus monkeys during the period of organogenesis was not associated with maternal toxicity or effects on embryo-fetal development at exposure levels approximately 4 to 31-times higher than those observed at a recommended dose range of 75 mg to 300 mg based on area under the curve (AUC).

Metabolism

The pharmacokinetics of tremelimumab-actl was studied in patients with other solid tumors following administration of doses 1 mg/kg, 3 mg/kg, and 10 mg/kg (1- to 10-times the approved recommended dosage) administered once every 4 weeks for 4 doses. The pharmacokinetics of tremelimumab-actl as a single dose of 300 mg were evaluated in patients with HCC.

• Oct 21, 2022BLABLA761289Astrazeneca Ab

1. 1Death3328.4%
2. 2Diarrhoea2767.0%
3. 3Malignant Neoplasm Progression2325.9%
4. 4Pyrexia2135.4%
5. 5Colitis1734.4%
6. 6Cytokine Release Syndrome1634.1%
7. 7Immune-mediated Enterocolitis1423.6%
8. 8Rash1323.4%
9. 9Liver Disorder1223.1%
10. 10Pneumonia1102.8%
11. 11Pneumonitis972.5%
12. 12Myocarditis952.4%
13. 13Hepatic Function Abnormal912.3%
14. 14Immune-mediated Hepatic Disorder902.3%
15. 15Interstitial Lung Disease882.2%

The 10 most recently updated of 275 ClinicalTrials.gov registrations naming Tremelimumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
  Recruiting · Phase 2 · Interventional · 70 enrolled · National Cancer Institute (NCI)
  NCT03606967updated 2026-06-12
• Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma
  Recruiting · Phase 3 · Interventional · 1,220 enrolled · AstraZeneca
  NCT06921785updated 2026-06-11
• STRIDE (Durvalumab + Tremelimumab) With Lenvatinib vs STRIDE Alone in Unresectable Hepatocellular Carcinoma
  Recruiting · Phase 2 · Interventional · 140 enrolled · Canadian Cancer Trials Group
  NCT06880523updated 2026-06-09
• GLP-1 RA Plus SOC Treatment in First-line, Metastatic Pancreatic, Colorectal, or Hepatocellular Cancer
  Not yet recruiting · Early phase 1 · Interventional · 30 enrolled · University of Arizona
  NCT07627191updated 2026-06-08
• Combined Treatment of Durvalumab, Bevacizumab, Tremelimumab and Transarterial Chemoembolization (TACE) in Subjects With Hepatocellular Carcinoma or Biliary Tract Carcinoma
  Active not recruiting · Phase 2 · Interventional · 27 enrolled · National Cancer Institute (NCI)
  NCT03937830updated 2026-06-08
• Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin
  Active not recruiting · Phase 3 · Interventional · 712 enrolled · AstraZeneca
  NCT04960709updated 2026-06-04
• A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma
  Active not recruiting · Phase 2 · Interventional · 433 enrolled · MedImmune LLC
  NCT02519348updated 2026-06-03
• Single cEll pRofiling PErsistaNce To ImmuNothErapy
  Recruiting · Phase 2 · Interventional · 60 enrolled · Vall d'Hebron Institute of Oncology
  NCT06680739updated 2026-06-01
• TheraSphere With Durvalumab and Tremelimumab for HCC
  Active not recruiting · Phase 2 · Interventional · 100 enrolled · Boston Scientific Corporation
  NCT05063565updated 2026-06-01
• Testing the Addition of an Immunotherapy Drug, Tremelimumab, to the PARP Inhibition Drug, Olaparib, for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer
  Active not recruiting · Phase 2 · Interventional · 61 enrolled · National Cancer Institute (NCI)
  NCT04034927updated 2026-05-28

Frequently asked questions

How does Tremelimumab work?

CTLA-4 is a negative regulator of T-cell activity. Tremelimumab-actl is a monoclonal antibody that binds to CTLA-4 and blocks the interaction with its ligands CD80 and CD86, releasing CTLA-4-mediated inhibition of T-cell activation.

What is Tremelimumab used for?

According to FDA labeling, Tremelimumab carries indications including: IMJUDO is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated: • in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). ( 1.1 ) • in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Tremelimumab?

Tremelimumab is classified as Other monoclonal antibodies and antibody drug conjugates, CTLA-4-directed Blocking Antibody, CTLA-4-directed Antibody Interactions, Cellular Proliferation Alteration, Increased T Lymphocyte Activation.

What are the brand names for Tremelimumab?

Tremelimumab is marketed under brand names including Imjudo.

What are the contraindications for Tremelimumab?

Tremelimumab labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.