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Durvalumab (MEDI4736) Plus Cediranib in Patients With Metastatic Uveal Melanoma | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

Durvalumab (MEDI4736) Plus Cediranib in Patients With Metastatic Uveal Melanoma

Phase II, Open-Label Study of Preliminary Efficacy of Durvalumab (MEDI4736) in Combination With Cediranib in Patients With Metastatic Uveal Melanoma

NCT04184518•Grupo Español Multidisciplinar de Melanoma

View on ClinicalTrials.gov

Summary

Phase II clinical trial aimed to evaluate the efficacy of the combination of cediranib and durvalumab in patients with metastatic uveal melanoma (mUM) with biopsiable disease at first line of after failure to first line systemic or liver directed therapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Any concurrent chemotherapy, IMP, biologic, or hormonal therapy for cancer treatment different to cediranib and/or durvalumab. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
•Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.
•Major surgery within a minimum of 2 weeks prior to inclusion; patients must have recovered from any effects of any major surgery prior to inclusion. Note: Local surgery of isolated lesions for palliative intent and minor surgeries performed to obtain biological material for the study (i.e. liver biopsy) are acceptable.
•History of allogeneic organ transplantation.
•Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion: Patients with vitiligo or alopecia. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement. Any chronic skin condition that does not require systemic therapy. Patients without active disease in the last 5 years may be included but only after consultation with the Coordinating Investigator. Patients with celiac disease controlled by diet alone.
•Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, compromise cediranib absorption, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
•History of another primary malignancy, except for: Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IMP and of low potential risk for recurrence. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. Adequately treated carcinoma in situ without evidence of disease.
•History of active primary immunodeficiency.
•Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
•Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection). Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
+12 more criteria

Exclusion Criteria

•Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. Patients must have at least 1 biopsiable liver metastasis.
•Patients must be 18 years of age or older at time of study entry.
•Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
•Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
•Adequate normal organ and marrow function as defined below: Haemoglobin ≥9.0 g/dL, Absolute neutrophil count (ANC) \> 1.5 x 109/L (\> 1500 per mm3), Platelet count ≥ 100 x 109/L (\>100,000 per mm3). Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with Coordinating Investigator. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \<2.5 x upper limit of normal (ULN) in the absence of liver metastases. If liver metastases are present, both AST and ALT must be no more than 5 x ULN. Creatinine clearance \>30 ml/min calculated by Cockcroft-Gault or another validated method. Urine protein:creatinine ratio (UPC) ≤1 or ≤2+ proteinuria on 2 consecutive dipsticks taken no less than 1 week apart. Subjects with 2+ proteinuria on dipstick must also have UPC \< 0.5 on 2 consecutive samples.
•Postmenopausal or evidence of non-childbearing status for women of childbearing potential as confirmed by a negative urine or serum pregnancy test within 7 days prior to inclusion. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: Amenorrheic for ≥1 year in the absence of chemotherapy and/or hormonal treatments. Luteinizing hormone (LH) and/or follicle stimulating hormone and/or estradiol levels in the post-menopausal range. Radiation induced oophorectomy with last menses \>1 year ago. Chemotherapy induced menopause with \>1 year interval since last menses. Surgical sterilization (bilateral oophorectomy or hysterectomy) Women \<50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy). Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \>1 year ago, had chemotherapy-induced menopause with last menses \>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
•Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
•Must have a life expectancy of at least 12 weeks
•Subjects must be able to swallow and retain oral medications and be without clinically significant gastrointestinal illnesses that would preclude absorption of cediranib.
•Adequately controlled BP: Systolic BP ≤140 mmHg and diastolic BP ≤90 mmHg in the presence or absence of a stable regimen of antihypertensive therapy.
+8 more criteria

Locations (5)

Instituto Catalá d'Oncología L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

H. U. Virgen de la Victoria

Málaga, Spain

Clínica Universidad de Navarra

Pamplona, Spain

H.U. Virgen Macarena

Seville, Spain

Hospital General Universitario de Valencia

Valencia, Spain

Key Dates

Start Date

May 1, 2020

Primary Completion Date

December 1, 2021

Completion Date

December 1, 2021

Last Updated

June 2, 2020

Conditions

Uveal MelanomaMetastatic Cancer

Interventions

Cediranib Maleate

DRUG

Durvalumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 2, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Durvalumab (MEDI4736) Plus Cediranib in Patients With Metastatic Uveal Melanoma

Inclusion Criteria

Exclusion Criteria

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