Study Summary
This trialwill study a 3-drug combo for recurrent endometrial & ovarian cancer to see if it's safe & effective w/ manageable side effects.
Eligible Conditions
- Platinum-Resistant Fallopian Tube Carcinoma
- Recurrent Ovarian Cancer
- Platinum-Resistant Primary Peritoneal Carcinoma
- Recurrent Primary Peritoneal Carcinoma
- Endometrial Cancer
- Platinum-resistant Ovarian Cancer
- Recurrent Fallopian Tube Cancer
Treatment Effectiveness
Phase-Based Effectiveness
Phase 2
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: through study completion, an average of 1 year
Year 1
Objective tumor response
Progression free survival
Safety and Toxicity
Trial Safety
Phase-Based Safety
This is further along than 68% of similar trials
Side Effects for
Trastuzumab
59%Leukopenia
56%Neutropenia
34%Hypoaesthesia
31%Agranulocytosis
22%Alopecia
22%Asthenia
19%Pyrexia
16%Nail disorder
16%Oedema peripheral
16%Diarrhoea
16%Hypophagia
13%Alanine aminotransferase increased
13%Neurotoxicity
13%Cough
13%Vomting
9%Aspartate aminotransferase increased
9%Headache
9%Musculoskeletal pain
9%Chest discomfort
9%Rash
9%Pigmentation disorder
9%Nausea
9%Bone marrow failure
9%Anaemia
6%Transaminases increased
6%Insomnia
6%Nasopharyngitis
6%Paronychia
6%Flushing
6%Face oedema
6%Constipation
6%Mouth ulceration
6%Thrombocytopenia
3%Cataract
3%Infection
3%Upper respiratory tract infection
3%Completed suicide
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Trial Design
1 Treatment Group
Treatment (paclitaxel, lenvatinib, pembrolizumab)
1 of 1
Experimental Treatment
38 Total Participants · 1 Treatment Group
Primary Treatment: Paclitaxel · No Placebo Group · Phase 2
Treatment (paclitaxel, lenvatinib, pembrolizumab)Experimental Group · 3 Interventions: Lenvatinib, Paclitaxel, Pembrolizumab · Intervention Types: Drug, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
FDA approved
Paclitaxel
FDA approved
Pembrolizumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year
Who is running the clinical trial?
Floor BackesLead Sponsor
2 Previous Clinical Trials
28 Total Patients Enrolled
1 Trials studying Fallopian Tube Carcinoma
26 Patients Enrolled for Fallopian Tube Carcinoma
Floor Backes, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
5 Previous Clinical Trials
302 Total Patients Enrolled
1 Trials studying Fallopian Tube Carcinoma
26 Patients Enrolled for Fallopian Tube Carcinoma
Eligibility Criteria
Age 18+ · Female Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are allowed to have had treatment with PD-1/PD-L1 inhibitors or weekly paclitaxel, as long as you did not recently stop the treatment because of side effects or toxicity.