Study for Patients with Lung or Urinary Tract Cancer Continuing Treatment with Durvalumab, Infliximab, and Mycophenolate Mofetil

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What is this study about?

This clinical trial is focused on patients with certain types of cancer, including Locally Advanced, Unresectable Non-Small Cell Lung Cancer, Post-Chemotherapy Urothelial and Non-Urothelial Carcinoma of the Urinary Tract, Advanced or Metastatic Non-Small Cell Lung Cancer in patients who have not received prior treatment, and First-line Extensive Disease Small-Cell Lung Cancer. The study involves the use of a medication called Durvalumab, also known by its code name MEDI4736. This medication is given as an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of this study is to continue providing treatment to patients who have completed a previous cancer study with Durvalumab and are still benefiting from it, according to their doctor. The study will monitor the safety and how well patients tolerate the treatment. In addition to Durvalumab, the study may also involve other medications such as Infliximab and Mycophenolate Mofetil, which are used for different purposes. Infliximab is administered through an infusion, while Mycophenolate Mofetil is taken orally in capsule form.

Participants in this study will continue to receive their treatment as long as they are benefiting from it. The study will keep track of any serious side effects that occur up to 90 days after the last dose of the study treatment. This trial aims to ensure that patients who are doing well on their current treatment can continue to receive it safely.

1 joining the study

Upon joining the study, the patient must provide a signed and dated informed consent form (ICF). This document confirms the patient’s understanding and agreement to participate in the study.

The patient must be currently benefiting from a previous study involving an AstraZeneca (AZ) compound and must be eligible to continue treatment with durvalumab.

2 treatment administration

The patient will receive durvalumab as a fixed dose of 1500 mg every four weeks (Q4W).

The administration of durvalumab is done through intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein.

3 monitoring and safety

Throughout the study, the patient’s safety and the tolerability of the treatment will be closely monitored.

Any serious adverse events (SAEs) will be reported and monitored for up to 90 days after the last dose of the study treatment.

4 study duration

The study is designed to continue providing treatment to patients who benefit from it until the estimated end date of May 8, 2025.

The study aims to ensure that patients who have completed a previous oncology study with durvalumab can continue to receive treatment if they are still benefiting from it.

Who Can Join the Study?

The patient must provide a signed and dated written document called an Informed Consent Form (ICF), which shows they agree to participate in the study.
The patient should currently be benefiting from a treatment in a previous study, as determined by the study doctor. This means the treatment is helping them, and they are using a specific medicine from the previous study that has either finished or reached the maximum time allowed.
The patient must be able to receive a medicine called durvalumab at a fixed dose of 1500 mg every four weeks when they start the study.
Both male and female patients can participate in the study.
The study includes patients who might be considered part of a vulnerable population, meaning they may need extra care or protection.

Who Cannot Join the Study?

Patients with other types of cancer that are not part of the study.
Patients who have not completed previous treatments required by the study.
Patients with medical conditions that could interfere with the study treatment.
Patients who are unable to follow the study procedures or attend required visits.
Patients who are pregnant or breastfeeding.
Patients with severe allergies or reactions to the study medication.
Patients with serious infections or illnesses that could affect their participation.
Patients who are currently participating in another clinical trial.
Patients with a history of substance abuse that could interfere with the study.
Patients who have had a recent major surgery that could impact their health during the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Koranyi National Institute For Pulmonology	Budapest	Hungary
Comite Entreprise Paul Papin	Angers	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Centr Georges Francois Leclerc	Dijon	France
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Zachodniopomorskie Centrum Onkologii	Szczecin	Poland
Semmelweis University	Budapest	Hungary
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD	Sofia	Bulgaria
University Hospital Olomouc	Olomouc	Czechia
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Wojewodzki Szpital Zespolony W Elblagu SPZOZ	Elblag	Poland
Ijzwnspk Onexgodfcm Vsrtuj	Padua	Italy
Ffqai Vgrlalojr Seyfe Gcuveih Exlzdgfg Olxhnx Knzerx	Szekesfehervar	Hungary
Inxkhjgx Rulnikdv Dh Ccmgtg Dz Mwuqifqvnrd	Montpellier	France
Parvpkwubofnh Ojvqwtrpv	Oldenburg In Holstein	Germany
Ipmioeyn Dm Cyysujgedgvu Socrybscwf Euflsi	STRASBOURG, Alsace	France
Ouzztub Guif	Guetersloh	Germany
Wwanayxkgndpaeysyvj Cfhfccw Cajxpu Plqf W Oafrhtqsq	Olsztyn	Poland
Synfjchcoz Spoplhhs Syhcqr	Suceava	Romania
Mhhj Sglvkho Lbdb	Sofia	Bulgaria
Nm Muo Gzrbz Sgju	Elblag	Poland
Hgxnlvus Veef daqxyvex	Barcelona	Spain
Crilpy Dk Lndcw Cwpfqk Lu Cfwyxb Eotchx Msogeib	Rennes	France
Icxpmore Rwpmjdtsl Pll Lg Sxqech Dvx Tpgfkr Dufz Ajgtvve Imwh Scotwi	Meldola	Italy
Apkbjasdpk Podpliac Hwlxntdz Dv Mtdtoepno	Marseille	France
Uifhosodpfpgkakzh Cstllm Bwvznpxjni Ds Rftm	Rome	Italy
Arfzuxf Oxzqemfglbw Ptc Louvkswzpnbhgtizt Cdjqouxguk	Catania	Italy
Bqmkjggh Ujioacmhjj Htazaluz Codfec	Besançon	France
Czvmqv Hdsfeysuxik Rkfwftsw Uatapagmvhmvu Dq Tcquq	Tours	France
Ukvsyjlsmmhdympthabhx Mcizmwie Aks	Munster	Germany
Gjcflvormvlqyhjde Vxfyiwgll Pehb Aiuxfl Eghqtxcx Ocsogf Kdgaem	Gyor	Hungary
Ndbnqwnu Iiugfgsl Ojvddiufa Iui Mcyfw Sykxfqmsiblqfiusckobiomlwxam Illvnehf Brnielna	Cracow	Poland
Aiqyaht Ulu Tbuepkj Sbp Erh	Arezzo	Italy
Gwtlhtr Ozucaanjuuw Hbkekhbj Oj Kqrahgqi Awabw Aceylvhdc	Kifissia	Greece
Hawpqsdp Di Lu Sshih Cesr I Szod Psa	Barcelona	Spain
Ccfkdr Llft Bkanti	Lyon	France
Cklgvrk Ohetdolcg Ioq Poldh Fujbqxiiqr Lulidhgtidg W Bcvehyxyqf	Bydgoszcz	Poland
Swe Cyrlcgo Fkyzmkiwk Hmntipya	Rome	Italy
Fdyntokqa Pgwt Lw Impghpqfslbsk Baeedoysj Dkl Huixtqpz Uzycgteucgexh Lb Pzj	Madrid	Spain
Ivuwkzfa Twgkiu Bjpr Gojfvpea Pmamn Ic	Bari	Italy
Giqwp Huwqhfv Dl Cjegvztsy	Charleroi	Belgium
Wetoqeggtmz Wivbqeczsvxkxbiiurch Cbjwzxo Oflxooeil I Tkbpdwztbruoj Iv Myqyljddfqo W Lbnvi	Lodz	Poland
Ipkybeuf Mwr Syp z owfi	Lodz	Poland
Bvuqqjdzjmlp Cmkflpd Ocjpmrkwo Irr Mkvnh Smtmrbwyvttjhbvdyt W Bbifnuhixcx	Bialystok	Poland
Fdduxfrefl Ivqphmhatv Ixoorygd Ncdnwtylted Badga	Milan	Italy
Huyflwhn Cjqph dsx Syx	Marbella	Spain
Adbkben Ottwoyqffjh Umppfsqklbibu Prvrvf	Pisa	Italy

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	31.12.2021
Bulgaria	Recruiting	31.12.2021
Czechia	Recruiting	31.12.2021
France	Recruiting	31.12.2021
Germany	Recruiting	31.12.2021
Greece	Recruiting	31.12.2021
Hungary	Recruiting	31.12.2021
Italy	Recruiting	31.12.2021
Poland	Recruiting	31.12.2021
Romania	Not recruiting	31.12.2021
Spain	Recruiting	31.12.2021

Trial locations

Investigated Drugs:

Durvalumab is a medication used in this clinical trial. It is an immunotherapy drug that helps the body’s immune system fight cancer. It works by blocking a specific protein that can stop the immune system from attacking cancer cells. This allows the immune system to better recognize and destroy cancer cells. In this trial, patients who have previously benefited from durvalumab in another study will continue to receive it to see if it continues to help them.

Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) – This is a type of lung cancer where the tumor has spread to nearby tissues or lymph nodes but cannot be surgically removed. It is not yet spread to distant parts of the body. The disease often causes symptoms like persistent cough, chest pain, and difficulty breathing. As it progresses, it may lead to more severe respiratory issues and general weakness.

Post-Chemotherapy Urothelial and Non-Urothelial Carcinoma of the Urinary Tract – This condition refers to cancer that affects the urinary tract, including the bladder, ureters, and kidneys, after chemotherapy treatment. Urothelial carcinoma is the most common type, but non-urothelial types can also occur. The disease may cause symptoms such as blood in the urine, frequent urination, and pain during urination. Over time, it can lead to more severe urinary problems and discomfort.

Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) in Treatment Naive Patients with Epidermal Growth Factor Receptor (EGFR) and Anaplastic Lymphoma Kinase (ALK) Wild Type Tumour Pathology – This form of lung cancer is characterized by its spread beyond the lungs in patients who have not received prior treatment. The tumors do not have mutations in the EGFR or ALK genes. Symptoms may include persistent cough, weight loss, and fatigue. As the disease advances, it can lead to more significant respiratory and systemic issues.

First-line Patients with Extensive Disease (Stage IV) Small-Cell Lung Cancer (SCLC) – This is an aggressive form of lung cancer that has spread widely throughout the body. It is often diagnosed at an advanced stage due to its rapid progression. Common symptoms include coughing, chest pain, and shortness of breath. As the disease progresses, it can cause significant health deterioration and impact various bodily functions.

Trial ID:

2023-507337-22-00

Protocol code:

D4191C00137 ROSY-D

NCT ID:

NCT05303532

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study for Patients with Lung or Urinary Tract Cancer Continuing Treatment with Durvalumab, Infliximab, and Mycophenolate Mofetil

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?