Tremelimumab

Generic Name: Tremelimumab

Brand Names: Imjudo, Tremelimumab AstraZeneca

Drug Type: Biotech

Chemical Formula: -

CAS Number: 745013-59-6

Unique Ingredient Identifier: QEN1X95CIX

Background: Tremelimumab, formerly known as ticilimumab, is a fully human IgG2 monoclonal antibody directed against cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4). CTLA-4 is a cell surface receptor expressed on activated T cells to act as a negative regulator for T cells. By binding to CTLA-4, tremelimumab enhances T cell-mediated killing of tumours and reduces tumour growth. Because CTLA-4 is an immune checkpoint that plays a vital role in regulating T cell-mediated immune response, tremelimumab is considered an immune checkpoint inhibitor, which is an emerging cancer immunotherapy drug class.

Tremelimumab was first approved by the FDA in October 2022 to be used in combination with durvalumab to treat hepatocellular carcinoma. It is also being investigated in other cancers, such as colon cancer, pancreatic cancer, non-small cell lung cancer (NSCLC), and malignant melanoma. After receiving an EMA Committee for Medicinal Products for Human Use (CHMP) recommendation in December 2022, tremelimumab was approved for combined use with durvalumab.

Indication: Tremelimumab is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma in combination with durvalumab. It is also indicated 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.

Associated Conditions: Metastatic Non-Small Cell Lung Cancer, Unresectable Hepatocellular Carcinoma (HCC)

Associated Therapies: -

Clinical Trials

Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN)

Phase 3

Active, not recruiting

Conditions: Small Cell Lung Carcinoma Extensive Disease

Interventions: Drug: Durvalumab
Drug: Carboplatin
Drug: Tremelimumab
Drug: Cisplatin
Drug: Etoposide

First Posted Date: 2017-02-06

Last Posted Date: 2024-10-23

Lead Sponsor: AstraZeneca

Target Recruit Count: 987

Registration Number: NCT03043872

Locations: 🇺🇦
Research Site, Zaporizhzhia, Ukraine

Durvalumab and Tremelimumab in Treating Participants With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Phase 2

Recruiting

Conditions: Recurrent Ovarian Carcinoma
Refractory Ovarian Carcinoma
Platinum-Resistant Fallopian Tube Carcinoma
Platinum-Resistant Ovarian Carcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Primary Peritoneal Carcinoma
Platinum-Resistant Primary Peritoneal Carcinoma
Refractory Fallopian Tube Carcinoma
Refractory Primary Peritoneal Carcinoma

Interventions: Biological: Durvalumab
Biological: Tremelimumab

First Posted Date: 2017-01-20

Last Posted Date: 2024-03-25

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 120

Registration Number: NCT03026062

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

A Study of Durvalumab With or Without Tremelimumab in Endometrial Cancer

Phase 2

Completed

Conditions: Endometrial Cancer
Endometrial Carcinosarcoma
Endometrial Carcinoma
Endometrial Cancer Recurrent
Endometrial Carcinoma, Recurrent

Interventions: Drug: Durvalumab
Drug: Tremelimumab

First Posted Date: 2017-01-09

Last Posted Date: 2024-02-06

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 80

Registration Number: NCT03015129

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 4 locations

Study of Durvalumab and Tremelimumab After Radiation for Microsatellite Stable Metastatic Colorectal Cancer Progressing on Chemotherapy

Phase 2

Completed

Conditions: Colorectal Cancer Metastatic

Interventions: Drug: durvalumab
Drug: Tremelimumab

First Posted Date: 2017-01-02

Last Posted Date: 2022-12-05

Lead Sponsor: NSABP Foundation Inc

Target Recruit Count: 33

Registration Number: NCT03007407

Locations: 🇺🇸
St. Joseph Mercy-Canton, Canton, Michigan, United States
🇺🇸
Centralia Oncology Clinic, Centralia, Illinois, United States
🇺🇸
UF Health Davis Cancer Pavilion and Shands Med Plaza, Gainesville, Florida, United States

and more 15 locations

Durvalumab, an Anti-PDLI Antibody, and Tremelimumab, an Anti-CTLA4 Antibody, and Chemoradiation Before Surgery for Esophageal Cancer

Phase 1

Recruiting

Conditions: Esophageal Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma

Interventions: Biological: durvalumab
Drug: carboplatin AUC 2/paclitaxel
Radiation: External beam radiation (EBRT)
Procedure: esophagogastrectomy
Drug: Tremelimumab

First Posted Date: 2016-11-11

Last Posted Date: 2024-10-16

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 79

Registration Number: NCT02962063

Locations: 🇺🇸
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Westchester, Harrison, New York, United States

and more 4 locations

Olaparib, Durvalumab, and Tremelimumab in Treating Patients With Recurrent or Refractory Ovarian, Fallopian Tube or Primary Peritoneal Cancer With BRCA1 or BRCA2 Mutation

Phase 2

Completed

Conditions: Ovarian Serous Adenocarcinoma
BRCA1 Gene Mutation
BRCA2 Gene Mutation
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma

Interventions: Biological: Durvalumab
Other: Laboratory Biomarker Analysis
Drug: Olaparib
Biological: Tremelimumab

First Posted Date: 2016-11-02

Last Posted Date: 2024-11-19

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 40

Registration Number: NCT02953457

Locations: 🇺🇸
The Feinstein Institute for Medical Research/Lennox Hill Hospital, New York, New York, United States
🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States

Durvalumab in Combination With Tremelimumab in Subjects With Advanced Rare Solid Tumors

Phase 2

Recruiting

Conditions: Cancer
Rare Disease

Interventions: Drug: Durvalumab
Drug: Tremelimumab

First Posted Date: 2016-10-19

Last Posted Date: 2024-04-02

Lead Sponsor: Prisma Health-Upstate

Target Recruit Count: 150

Registration Number: NCT02938793

Locations: 🇺🇸
Greenville Health System Cancer Institute, Greenville, South Carolina, United States

Durvalumab and Tremelimumab With or Without High or Low-Dose Radiation Therapy in Treating Patients With Metastatic Colorectal or Non-small Cell Lung Cancer

Phase 2

Active, not recruiting

Conditions: Stage IV Colorectal Cancer AJCC v7
Stage IVA Colorectal Cancer AJCC v7
Metastatic Lung Non-Small Cell Carcinoma
Stage IV Lung Non-Small Cell Cancer AJCC v7
Metastatic Colorectal Carcinoma
Stage IVB Colorectal Cancer AJCC v7

Interventions: Biological: Durvalumab
Radiation: Radiation Therapy
Biological: Tremelimumab

First Posted Date: 2016-09-05

Last Posted Date: 2025-01-06

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 110

Registration Number: NCT02888743

Locations: 🇺🇸
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

and more 39 locations

Durvalumab and Tremelimumab in Patients With Advanced Rare Tumours

Phase 2

Conditions: Advanced Rare Tumours

Interventions: Drug: Durvalumab
Drug: Tremelimumab

First Posted Date: 2016-08-25

Last Posted Date: 2022-01-26

Lead Sponsor: Canadian Cancer Trials Group

Target Recruit Count: 140

Registration Number: NCT02879162

Locations: 🇨🇦
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
🇨🇦
CancerCare Manitoba, Winnipeg, Manitoba, Canada
🇨🇦
BCCA - Vancouver Cancer Centre, Vancouver, British Columbia, Canada

and more 10 locations

Gemcitabine and Nab-Paclitaxel vs Gemcitabine, Nab-Paclitaxel, Durvalumab and Tremelimumab as 1st Line Therapy in Metastatic Pancreatic Adenocarcinoma

Phase 2

Active, not recruiting

Conditions: Pancreatic Adenocarcinoma

Interventions: Drug: Gemcitabine
Drug: Nab-paclitaxel
Drug: Durvalumab
Drug: Tremelimumab

First Posted Date: 2016-08-25

Last Posted Date: 2024-03-12

Lead Sponsor: Canadian Cancer Trials Group

Target Recruit Count: 180

Registration Number: NCT02879318

Locations: 🇨🇦
BCCA - Vancouver Cancer Centre, Vancouver, British Columbia, Canada
🇨🇦
Kingston Health Sciences Centre, Kingston, Ontario, Canada
🇨🇦
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada

and more 24 locations

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