Clinical trial · Interventional
Determine if Either of 2 Doses of Study Drug Given With a Low-dose of Cyclophosphamide After a Complete or Partial Response to a Platinum-based Second-line Therapy in Women With Recurrent Ovarian Carcinoma Results in a Longer Time to Progression When Compared to the First Time to Progression.
An Open-label Phase II Study of Two Dose Levels of EMD 273066 Administered With Low-dose Cyclophosphamide Following Objective Response to Second-line Chemotherapy in Women With Recurrent Ovarian Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Th trial got cancelled and no subjects signed informed consent form (ICF); study design not appropriate any longer.
Summary
Brief summary (as posted)
The purpose of this study is to determine if either of two doses of EMD 273066 when given with a low dose of cyclophosphamide will result in a second time to progression that is as long or longer than the first time to progression
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tucotuzumab celmoleukin (EMD 273066) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tucotuzumab celmoleukin (EMD 273066)
- interventionNames
- Drug: Tucotuzumab celmoleukin (EMD 273066)
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed written informed consent * Age 18 years or older * Have histologically documented ovarian carcinoma (including primary peritoneal carcinoma) * Have archival tumor tissue available for EpCAM expression determination by immunohistochemistry * Received first-line platinum-based chemotherapy of up to 8 cycles (approximately 15 to 24 weeks) * Experienced a complete response to first-line platinum-based chemotherapy * Experienced a platinum-free interval of at least 6 but not more than 24 months starting at the end of the last cycle of first-line chemotherapy until recurrence * Treatment with Avastin (bevacizumab) is permitted during first-line platinum-based chemotherapy through TTP and platinum-based reinduction therapy up to 28 days prior to start of EMD 273066 * Experienced a partial or complete response after up to 8 cycles of second-line platinum-based chemotherapy * Have a CT/MRI scan within 4 weeks prior to starting treatment * Be able to start cyclophosphamide and EMD 273066 treatment within 3 to 5 weeks of completion of second-line chemotherapy * KPS ≥70% * No clinical history of significantly impaired renal function or chronic kidney disease. Must have an estimated glomerular filtration rate ≥50 mL/min determined by the Cockgroft-Gault-formula * WBC count ≥2.5x10³/µL (or total granulocytes ≥1x10³/µL) * Absolute lymphocyte count (ALC) ≥0.5x103/µL * Platelet count ≥100,000/µL * Hemoglobin (Hgb) level ≥9 g/dl * ALT and AST ≤2.5xULN, total bilirubin \<1.5xULN * Serum sodium, potassium and phosphorus within normal limits * Serum amylase within normal limits * Serologic testing within 4 weeks prior to starting study treatment with negative results for hepatitis C virus (HCV), human immunodeficiency virus (HIV) and hepatitis B virus (HBV) demonstrated by negative hepatitis B core antibody (HBc Ab) and hepatitis B surface antigen (HbsAg) * Negative pregnancy test and willingness to use effective contraception for the study duration and 1 month thereafter if of procreative potential Exclusion Criteria: * Dyspnea at rest, exercise intolerance * In any subject with clinically significant non-malignant pulmonary disease: Pulmonary function testing (to include Forced Vital Capacity \[FVC\] and 1-second Forced Expiratory Volume \[FEV-1\]) showing \<70% of predicted values for FVC or FEV-1 and/or DLCO \<50%. * In any subject with pulmonary or pleural metastatic disease: Arterial oxygen saturation at rest measured transcutaneously on room air \< 90% or increased risk for respiratory compromise related to IL2 exposure in the judgment of the investigator. * ECG with evidence of clinically significant disease within 4 weeks prior to starting study treatment * Cardiac stress test (e.g., exercise or pharmacological thallium test; exercise or pharmacological echocardiography) with abnormal results within 4 weeks prior to starting treatment in subjects who have a history of coronary heart disease (myocardial infarction, angina pectoris or pathologic coronary angiography) * Any current evidence of congestive heart failure with NY Heart Association Grade 2 through 4 or echocardiogram with a left ventricular ejection fraction \<45% or other signs of clinical significant heart disease * History of repeated and clinically relevant episodes of syncope or other paroxysmal, ventricular, or other clinically significant arrhythmias * Evidence of active brain metastases * Previous malignancy other than ovarian cancer in the last 5 years except basal cell cancer of the skin or pre-invasive cancer of the cervix * Pregnant or lactating female * An immediate need for palliative radiotherapy or systemic corticosteroid therapy * Significant active infection * Major surgery, chemotherapy, or radiation within 21 days of starting study treatment * Received another experimental drug within 28 days of starting study treatment * Uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥100 mmHg) or hypotension (systolic ≤90 mmHg) * Presence of medically significant third space fluids such as pleural or pericardial effusions or edema of toxicity grade ≥2 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 \[17\]. * Exception allowed for disease-related peritoneal ascites unless patient requires frequent and repetitive paracentesis management. Previous diagnosis of an autoimmune disease involving a major organ system * Transplant recipient on immunosuppressive therapy * Acute esophageal or gastroduodenal ulcers * History of prior therapy or a serious uncontrolled medical disorder that in the Investigator's opinion would impair participation in the study
References
Publications (0)
Data not yet available