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A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination with Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients with Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC) (MYSTIC)

To assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of PFS and OS in patients with PD-L1- positieve (equal or greater than 25%) NSCLC.To assess the efficacy of MEDI4736 therapy compared to SoC in terms of…

Phase 1b study of safety and tolerability in patients treated with stereotactic radiotherapy combined with durvalumab and tremelimumab in stage 4 NSCLC

To assess safety and tolerability of the combination of SBRT and combined CTLA-4/PD-L1 inhibition. In addition immune modulatory effect of the combination of an ablative dose of radiotherapy to the primary tumor and response to durvalumab/…

Releasing the brakes on CD8+ T cells in the melanoma sentinel lymph node by pre-operative local administration of low-dose anti-CTLA-4 (tremelimumab)

1) To determine clinical safety and tolerability of local i.d. administration of a single dose of tremelimumab in clinical stage II melanoma patients scheduled to undergo a SLN procedure. 2) To ascertain the immunological effects of local i.d.…

A Phase II Open-Label, Multi-Center Study of MEDI4736 Evaluated as Single Agent or in Combination with Tremelimumab in Patients with Metastatic Pancreatic Ductal Adenocarcinoma

To determine the efficacy and safety of MEDI4736 evaluated as a single agent or in combination with tremelimumab in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) whose disease has progressed on 5-FU-containing or gemcitabine-…

A Phase 1 Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination with Tremelimumab (Anti-CTLA-4 Antibody) in Subjects with Advanced Solid Tumors

OBJECTIVESPrimary Objectives:To assess the safety and tolerability, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or the highest protocol-defined dose (in the absence of exceeding the MTD) for the…

A Phase III, Open-label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination with Tremelimumab, Determined by PD-L1 Expression, Versus Standard of Care in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB IV) who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC)

This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 versus Standard of Care in NSCLC patients with PD-L1-positive tumours and the combination of MEDI4736 plus tremelimumab (MEDI4736+…

A Phase 1 Multicenter, Open-label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Antitumor Activity of MEDI0562 in Combination with Immune Therapeutic Agents in Adult Subjects with Advanced Solid Tumors

Primary ObjectiveThe primary objective is to assess safety and tolerability, describe the dose limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or the maximum administered dose (MAD; in the absence of exceeding the MTD) for…

A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients with Advanced Solid Tumors

Determine the efficacy and safety (using objective response rate) of tremelimumab in patients with advanced solid tumors (UBC, PDAC, TNBC).

ICRA (Improve Checkpoint-blockade Response in Advanced urothelial cancer), an adaptive clinical study to determine efficacy of combining weekly paclitaxel with tremelimumab +/- durvalumab (MEDI4736)

The standard first-line therapy for mUC patients is platinum-based chemotherapy, most commonly cisplatin. For patients that progress during or after platinum-based chemotherapy, anti-PD(L)1 therapy can be used, showing durable responses in a subset…

A multicentre single arm phase II trial assessing the efficacy of immunotherapy, chemotherapy and stereotactic radiotherapy to metastases followed by definitive surgery or radiotherapy to the primary tumour, in patients with synchronous oligo-metastatic nonsmall cell lung cancer

This study has been transitioned to CTIS with ID 2024-511134-12-00 check the CTIS register for the current data. The objective of this trial is to evaluate progression-free survival in synchronous oligometastatic NSCLC patients treated with…

An Open-Label, Multi-Centre, Safety Study of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies

Main protocol:To assess the incidence, severity, nature, seriousness, intervention/treatment, outcome, and causality, including immune-relatedness, of adverse events of special interest (AESIs) in patients who are treated with durvalumab and…

A Phase III, Randomized, Multicenter, Open-Label, Comparative Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for the First-Line Treatment in Patients with Extensive Disease Small-Cell Lung Cancer (SCLC)

To assess the efficacy of durvalumab +tremelimumab + EP treatment compared with EP in terms of OS and the efficacy of durvalumab + EP treatment compared with EP in terms of OS

A Phase III, Randomized, Open-label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 Monotherapy and MEDI4736 in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Unresectable Stage IV Urothelial Cancer

To assess the efficacy of MEDI4736 + tremelimumab combination therapy versus SoC in terms of OS in patients with UC.

A Phase III Randomized, Open-Label, Multicenter Study to Determine the
Efficacy and Safety of Durvalumab in Combination With Tremelimumab
and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab
Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or
Who Refuse Cisplatin Undergoing Radical Cystectomy for Muscle Invasive
Bladder Cancer (VOLGA)

This study has been transitioned to CTIS with ID 2023-507342-84-00 check the CTIS register for the current data. (1) Main objective:Safety Run-In (SRI):To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC…

A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with Limited Stage Small-Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy

This study has been transitioned to CTIS with ID 2023-509602-29-00 check the CTIS register for the current data. Primary objectives:- To assess the efficacy of durvalumab monotherapy compared to placebo in terms of PFS- To assess the efficacy of…

EORTC ILOC study: Phase II of immunotherapy plus local tumor ablation (RFA or stereotactic radiotherapy) in patients with colorectal cancer liver metastases

The primary objective of this proof of concept study will be to investigate whether the combined use of local tumor ablation/radiation plus immunomodulating drugs may induce a significant immune response in patient with incurable liver metastases…

Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Durvalumab Monotherapy or Durvalumab in Combination with Tremelimumab in Pediatric Patients with Advanced Solid Tumors and Hematological Malignancies

Dose-finding:-To determine the adult equivalent exposure/MTD/recommended Phase II pediatric dose of durvalumab monotherapy and durvalumab in combination with tremelimumab-To determine the safety profile of durvalumab monotherapy, or durvalumab in…

A Phase Ib, Open-label, Single-center study to assess the safety of cancer-immunotherapy induction with Tremelimumab and Durvalumab prior to Chemoradiotherapy and/or Resection in the treatment of locally advanced NSCLC.

Primary Objective - To assess the safety of CIT-induction with Tremelimumab and Durvalumab, and CRT/R in stage III NSCLCSecondary objectives - To assess the efficacy of CIT-induction with Tremelimumab and Durvalumab , and CRT /R by establishing…