Carboplatin for Recurrent Fallopian Tube Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Recurrent Fallopian Tube Cancer+2 MoreCarboplatin - Drug
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This trial is testing pembrolizumab + carboplatin to treat ovarian, fallopian tube, or primary peritoneal cancer that has come back.

Eligible Conditions
  • Recurrent Primary Peritoneal Carcinoma
  • Recurrent Fallopian Tube Cancer
  • Recurrent Ovarian Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Up to 2 years

At 6 months
Progression-free survival
Rate of radiographic recurrence
Baseline and 2 years
Changes in T cell activation
Up to 2 years
Overall survival
PD-L2 expression
Programmed cell death ligand 1 (PD-L1) expression

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

10 MG/KG Ipilimumab + Paclitaxel/ Carbop
38%Alopecia
36%Anaemia
32%Nausea
31%Decreased appetite
31%Diarrhoea
30%Fatigue
25%Constipation
23%Neutropenia
20%Dyspnoea
19%Pyrexia
19%Vomiting
18%Rash
17%Cough
17%Asthenia
16%Arthralgia
16%Pruritus
16%Thrombocytopenia
15%Peripheral sensory neuropathy
14%Myalgia
13%Neuropathy peripheral
13%Insomnia
11%Hypokalaemia
10%Platelet count decreased
9%Pain in extremity
9%Leukopenia
9%Weight decreased
8%Hyponatraemia
8%Pneumonia
8%Alanine aminotransferase increased
8%Haemoglobin decreased
7%Malignant neoplasm progression
7%Back pain
7%Neutrophil count decreased
7%Aspartate aminotransferase increased
7%Dizziness
7%Bone pain
7%Haemoptysis
6%Hypomagnesaemia
6%Stomatitis
6%Headache
5%Abdominal pain
5%Oedema peripheral
5%Chest pain
5%Abdominal pain upper
5%White blood cell count decreased
5%Dehydration
4%Musculoskeletal pain
4%Febrile neutropenia
4%Paraesthesia
3%Colitis
2%Lung infection
2%Pulmonary embolism
2%Death
2%Mucosal inflammation
1%Chronic obstructive pulmonary disease
1%Cardio-respiratory arrest
1%Pulmonary haemorrhage
1%Pneumothorax
1%Interstitial lung disease
1%Urinary tract infection
1%Confusional state
1%Drug hypersensitivity
1%Cerebrovascular accident
1%Lung abscess
1%Multi-organ failure
1%Blood creatinine increased
1%Metastases to central nervous system
1%Atrial fibrillation
1%Disease progression
1%Renal failure
1%Liver function test abnormal
1%Lower respiratory tract infection
1%Lung neoplasm malignant
1%Pain
1%Acute kidney injury
1%Hypersensitivity
1%General physical health deterioration
1%Intestinal perforation
1%Infection
1%Pneumonitis
1%Respiratory failure
1%Syncope
1%Hyperglycaemia
1%Sudden death
1%Sepsis
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT01285609) in the 10 MG/KG Ipilimumab + Paclitaxel/ Carbop ARM group. Side effects include: Alopecia with 38%, Anaemia with 36%, Nausea with 32%, Decreased appetite with 31%, Diarrhoea with 31%.

Trial Design

1 Treatment Group

Treatment (carboplatin, pembrolizumab)
1 of 1

Experimental Treatment

22 Total Participants · 1 Treatment Group

Primary Treatment: Carboplatin · No Placebo Group · Phase 2

Treatment (carboplatin, pembrolizumab)Experimental Group · 2 Interventions: Carboplatin, Pembrolizumab · Intervention Types: Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

United States Department of DefenseFED
775 Previous Clinical Trials
201,880 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,070 Previous Clinical Trials
41,129,035 Total Patients Enrolled
10 Trials studying Recurrent Fallopian Tube Cancer
225 Patients Enrolled for Recurrent Fallopian Tube Cancer
University of WashingtonLead Sponsor
1,595 Previous Clinical Trials
1,568,754 Total Patients Enrolled
John B. LiaoPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had two or more lines of treatment.
You are willing and able to provide written informed consent/assent for the trial.
You have an absolute neutrophil count (ANC) of 1,500 or more per microliter of blood.
You have a platelet count of at least 100,000/mcL (performed within 14 days of treatment initiation).
You must agree to use contraception for the duration of the study.
You have a performance status of 0 or 1 on the ECOG performance scale.