Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Lung Neoplasms

Vascular Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Prostatic Neoplasms

Breast Neoplasms

Colorectal Neoplasms

Recurrence

Lymphoma

Leukemia

Thrombosis

Hemostatic Disorders

Blood Coagulation Disorders

Body Weight

Gastrointestinal Neoplasms

Intestinal Neoplasms

Lymphoproliferative Disorders

Myeloproliferative Disorders

Thromboembolism

Venous Thromboembolism

Venous Thrombosis

Urogenital Neoplasms

Digestive System Neoplasms

Lymphatic Diseases

Embolism

Embolism and Thrombosis

Lymphosarcoma

Chronic Myeloproliferative Disorders

Fibrinolytic Agents

Anticoagulants

All Drugs and Chemicals

Coagulants

Heparin

Hemostatics

Calcium heparin

Heparin, Low-Molecular-Weight

Tinzaparin

Dalteparin

Patients with objectively confirmed cancer associated venous thromboembolism receiving tinzaparin treatment to prevent recurrence of venous thromboembolism

Subcutaneous injection of 175 IU/kg once daily for 6 months

G Meyer, Professor

F Scotte, Dr

The purpose of this study is to validate the Ottawa score (risk of thromboembolic recurrences) in cancer patients with thromboembolic disease treated with tinzaparin (Innohep®)

The Ottawa score is a clinical predictive score aiming at stratifying thromboembolic recurrences in cancer patients according to identified clinical risk factors and histological type of the tumor. This score has never been validated externally in a prospective way in patients treated with tinzaparin. The objective of this observational prospective study is to enroll cancer patients with TED treated with tinzaparin for a planned period of 6 months and to collect data on thromboembolic recurrences, major hemorrhages, deaths and heparin-induced thrombocytopenia

Non Interventional Study of the Validation of the Ottawa Score in Cancer Patients With Venous Thromboembolism (VTE)

Prediction of Thromboembolic Recurrences in Cancer Patients With Venous Thromboembolic Disease (TED)

LEO Pharma

Endometrial Neoplasms

Uterine Neoplasms

Uterine Diseases

Genital Diseases

Genital Neoplasms, Female

Genital Diseases, Female

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Participants will receive fixed dose of selinexor 80 mg (or 60 mg for participants with a body mass index \[BMI\] less than \[\<\] 20 kilogram per meter square \[kg/m\^2\]) oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle.

Participants will receive matching placebo for selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle.

Dose: 80 mg (4 tablets) or 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral

Selinexor

Matching placebo for selinexor

This is a prospective, multicenter, double-blind, placebo-controlled, randomized Phase 3 study. The purpose of the study is to obtain evidence of efficacy for maintenance selinexor in participants with advanced or recurrent endometrial cancer. Participants with primary stage IV or recurrent disease who are in partial or complete response after having completed a single line of at least 12 weeks of taxane-platinum combo therapy will be randomized in a 2:1 manner to maintenance therapy with 80 milligram (mg) with selinexor once weekly (QW) or placebo until progression.

Maintenance With Selinexor/Placebo After Combination Chemotherapy in Participants With Endometrial Cancer [SIENDO]

A Randomized, Double-Blind, Phase 3 Trial of Maintenance With Selinexor/ Placebo After Combination Chemotherapy for Patients With Advanced or Recurrent Endometrial Cancer

Compare progression free survival of the two treatment arms as assessed by the investigator, per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

Time from randomization until documented PD or death due to any cause, whichever occurs first. Documented PD will be based on BICR assessments.

Time from randomization until date of death from endometrial cancer.

Time from randomization until date of death from any cause.

Time from randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first.

Time from randomization until the second documented disease progression or death due to any cause by any cause on any subsequent line of anticancer therapy.

Time from randomization until date of initiation of second therapy after discontinuation of study drug or death, whichever occurs first.

Best response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) among patients with PR as best response to prior chemotherapy.

Patient-reported outcomes will be measured by the EORTC QLQ C30 questionnaire.

Patient-reported outcomes will be measured by the EORTC QLQ-EN24 questionnaire.

Patient-reported outcomes will be measured by the EORTC EQ-5D-5L.

Belgium and Luxembourg Gynaecological Oncology Group

North-Eastern German Society of Gynaecologic Oncology

Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies

Spanish Research Group in Ovarian Cancer

The Central and Eastern European Gynecologic Oncology Group

Israel Society of Gynecologic Oncology

The GOG Foundation, Inc.

Karyopharm Therapeutics Inc

Gland and Hormone Related Diseases

Carcinoma

Stomach Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hypersensitivity

Neoplasms, Glandular and Epithelial

Ovarian Diseases

Endocrine Gland Neoplasms

Adnexal Diseases

Endocrine System Diseases

Gonadal Disorders

Neoplasms by Histologic Type

Male Urogenital Diseases

Gastrointestinal Diseases

Stomach Diseases

Ovarian Cancer

Stomach Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

Pembrolizumab

Lenvatinib

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Participants will receive pembrolizumab 200 milligram (mg) administered by intravenous (IV) infusion on Day 1 of each 21-day cycle plus lenvatinib 20 mg administered orally (PO) once daily (QD) during each 21-day cycle for up to 35 cycles.

200 mg administered by IV infusion on Day 1 of each 21-day cycle.

20 mg administered orally (PO) QD during each 21-day cycle.

Ronnie Shapira, MD

Ronnie Shappira, MD

This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) for the treatment of platinum sensitive recurrent ovarian cancer. Participants will receive pembrolizumab and lenvatinib.

This will be a phase-2, open-label, single-arm, single-center study to assess the effect of pembrolizumab and Lenvatinib combination therapy on platinum-sensitive recurrent ovarian cancer (ROC) patients.

Female patients 18 years of age or older with histologically-confirmed epithelial ovarian cancer (EOC) - excluding low grade tumors and mucinous histology - and documented disease recurrence following primary or interval debulking surgery and 1-2 prior lines of chemotherapy (including a frontline platinum-based regimen) and a platinum-free interval greater than 6 months will be eligible to enroll in the study.

Twenty-four patients will be included in the study. The study diagram is shown in Figure 1 and the schedule of assessments (SoA) is shown in Section 6.0. After signing the informed consent, eligible subjects according to the inclusion and exclusion criteria will receive oral Lenvatinib 20 mg once daily (QD) plus intravenous (IV) pembrolizumab 200 mg every three weeks (Q3W) until evident progressive disease by CT (RECIST), or unacceptable toxicity, or until completion of 35 treatment cycles with pembrolizumab.

Disease status will be evaluated radiologically by computed tomography (CT) every 9 weeks, in comparison to pretreatment CT, until progression. In case of study withdrawal due to other reasons, radiological evaluation will be maintained every 9 weeks until disease progression or patient's withdrawal of consent or a new anticancer regimen is given. Patients with contrast media allergy will undergo chest CT without contrast medium as well as abdominal and pelvic magnetic resonance imaging (MRI).

Toxicity will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Ver. 5.0 (NCI-CTCAE). Dose reductions and modification of Lenvatinib will be performed according to the indications in Section 5.2.3. Pembrolizumab dose will not be reduced but the dose can be delayed for up to 9 weeks in case of toxicity which requires steroid.

treatment and steroids withdrawal (refer to Section 5.2.2 on pembrolizumab dose interruptions). Refer to section 5.2.4 for dose modifications for overlapping toxicities.

Health-related quality of life will also be evaluated. Collateral research will focus on potential biomarkers of response to treatment and on micro- and macro-environmental changes occurring during the course of treatment. To that end, tumor biopsies, stool and vaginal swabs and blood (plasma, serum and peripheral blood mononuclear cells (PBMC)) samples will be collected at Screening and during the study. Analyses will be performed to determine pre- and post-treatment changes as well as differences between responders to treatment and non-responders.

Participants who stop study treatment after receiving 35 administrations of pembrolizumab for reasons other than disease progression or intolerability, or participants who attain a complete response (CR) and stop study treatment may be eligible for up to 1 year of treatment with pembrolizumab (17 cycles) ± Lenvatinib upon experiencing disease progression (Second Course Phase). Participants who complete treatment with pembrolizumab after 35 cycles (approximately 2 years) or CR will continue to receive Lenvatinib alone until disease progression, development of unacceptable toxicity, or withdrawal of consent.

Pembrolizumab and Lenvatinib for Platinum- Sensitive Recurrent Ovarian Cancer

A Phase II, Open Lable, Single Arm, Trial to Determine Efficacy and Safety of Lenvatinib in Combination With Pembrolizumab for Platinum- Sensitive Recurrent Ovarian Cancer

defined as the time from study treatment initiation to the first documented disease progression according to RECIST 1.1 or death from any cause.

defined as the percentage of evaluable patients with complete response (CR) or partial response (PR). Response will be evaluated by the Investigator according to RECIST 1.1.

defined as the time (in months) from initiation of treatment with pembrolizumab and Lenvatinib to subsequent chemotherapy treatment initiation.

defined as the time from study treatment initiation to death due to any cause.

To evaluate the impact of the treatment protocol on health-related quality of life (HR-QoL) as assessed by using the global score of the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30.

All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

Safety and tolerability assessed by CTCAE v5.0.

To evaluate the impact of the treatment protocol on health-related quality of life (HR-QoL) as assessed by using the ovarian cancer-specific protocol, (EORTC) QLQ-OV28 for participants treated with Lenvatinib in combination with pembrolizumab.

All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

Sheba Medical Center

M.D, Head onco-gynecological service, Principal Investigator

Kidney Diseases

Adenocarcinoma

Melanoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Renal Cell

Colonic Neoplasms

Skin Diseases

Urinary Bladder Neoplasms

Neuroendocrine Tumors

Urologic Neoplasms

Neoplasms, Germ Cell and Embryonal

Urologic Diseases

Urinary Bladder Diseases

Kidney Neoplasms

Breast Diseases

Neoplasms, Nerve Tissue

Nevus, Pigmented

Prostatic Diseases

Genital Diseases, Male

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Nevus

Nevi and Melanomas

Skin Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Renal Cell Carcinoma

Neuroendocrine Tumor

Clear Cell Renal Cell Carcinoma

Neuroepithelioma

Herbal and Botanical

Vaccines

Cola

Two intramuscular (IM) injections of V935 low dose (LD), 1 given every other week over a 3-week period.

Three electroporation (EP) injections of V934 (LD) , 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (LD) will be administered, 1 given every other week over a 3-week period.

Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.

Three EP injections of V934 (HD), 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) will be administered, 1 given every other week over a 3-week period.

Five EP injections of V934 (HD), 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) will be administered, 1 given every other week over a 3-week period.

Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.

Participants who complete Part A can enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster will be administered, 1 given every 2 weeks.

A 0.5 mL vaccine administered IM every 2 weeks as either a LD (1 x 10\^9 vector genomes/mL) or a HD (1 x 10\^11 vector genomes/mL).

V935

A 0.5 mL vaccine administered by EP as either a LD (0.5 mg plasmid/mL) or a HD (5.0 mg plasmid/mL).

V934-EP

This is a two-part study to test the safety, tolerability, and immune response for V934/V935 vaccine using a new prime-boost regimen in participants with selected solid tumors.

Two vaccines will be administered: V934-electroporation (EP) either low dose (LD) or high dose (HD), and V935 either LD or HD. In Part A, participants will be assigned to V935 vaccine alone or in combination with V934-EP. Part B will be an optional part of the study, offering V934-EP vaccine booster to participants who were enrolled in Part A.

A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002)

A Phase I Investigation of the Safety, Tolerability and Immunogenicity of V934/V935 hTERT Vaccination in Cancer Patients With Selected Solid Tumors

DLT was defined as a vaccine- or EP-related adverse event (AE) including the following: Hematological (Grade 3 neutropenia with fever, Grade 4 neutropenia ≥5 days, Grade 4 thrombocytopenia) or non-hematological AE, Grade 3, 4 or 5 with the exception of Grade 3 nausea, vomiting, diarrhea or serum glutamic oxaloacetic transaminase (SGOT) elevation, alopecia, Grade 3/4 creatinine phosphokinase (CPK) elevation or inadequately treated hypersensitivity. Any Grade 3/4 related AE that failed to return to ≤Grade 1 or baseline within 14 days was also considered a DLT.

This analysis includes the number of participants with AEs and serious AEs (SAEs) during the Treatment Period plus the Acute Follow-up (FU) Period (up to 30 days following last vaccination). An AE was defined as any unfavorable or unintended change in the structure, function or chemistry of the body temporally associated with the use of the product, whether or not considered related to the product, including any worsening of a preexisting condition which was temporally associated with the product. An SAE was defined as an AE resulting in death, was life-threatening, resulted in or prolonged hospitalization, was a congenital anomaly, a cancer, an overdose or other important medical event.

An Enzyme-Linked Immunosorbent Spot (ELISPOT) assay was planned to be used to demonstrate a cell mediated immune response to V935 and/or V934 in vaccinated participants. Collection of Peripheral Blood Mononuclear Cells (PBMCs) and serum took place at baseline (Screening and pre-vaccination Day 1), and various time points post vaccination across the three distinct regimens to be tested. A positive immune response was to be defined by a minimum number of spot-forming cells per million PBMC (SFC/10\^6 PBMCs) for the antigen well and a minimum n-fold increase in the antigen well over the control well.

Merck Sharp & Dohme LLC

Participants who completed Part A had the option to enter Part B.

Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.

Part A: V935 LD

Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Non Interventional Study of the Validation of the Ottawa Score in Cancer Patients With Venous Thromboembolism (VTE)	NCT03099031	Venous Thromboe...	Tinzaparin	18 Years -	LEO Pharma
Maintenance With Selinexor/Placebo After Combination Chemotherapy in Participants With Endometrial Cancer [SIENDO]	NCT03555422	Endometrial Can...	Selinexor Matching placeb...	18 Years -	Karyopharm Therapeutics Inc
Maintenance With Selinexor/Placebo After Combination Chemotherapy in Participants With Endometrial Cancer [SIENDO]	NCT03555422	Endometrial Can...	Selinexor Matching placeb...	18 Years -	Karyopharm Therapeutics Inc
Maintenance With Selinexor/Placebo After Combination Chemotherapy in Participants With Endometrial Cancer [SIENDO]	NCT03555422	Endometrial Can...	Selinexor Matching placeb...	18 Years -	Karyopharm Therapeutics Inc
Pembrolizumab and Lenvatinib for Platinum- Sensitive Recurrent Ovarian Cancer	NCT04519151	Ovarian Neoplas... Carcinoma, Ovar... Neoplasm of Sto... Ovarian Disease... Genital Neoplas... Ovarian Epithel... Urogenital Neop... Neoplasms, Glan...	Pembrolizumab Lenvatinib	18 Years -	Sheba Medical Center
A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002)	NCT00753415	Non-Small Cell ... Breast Cancer Melanoma Upper GI Tract ... Colon Carcinoma Renal Cell Carc... Bladder Carcino... Prostate Cancer	V935 V934-EP	18 Years -	Merck Sharp & Dohme LLC

Spots Global Cancer Trial Database for genital neoplasms