Study Summary
This trial is testing nivolumab in combination with carboplatin and paclitaxel versus the usual treatment of carboplatin and paclitaxel for anal cancer that has spread to other parts of the body.
Eligible Conditions
- Anal Squamous Cell Carcinoma (Metastatic)
- Stage IIIA Anal Cancer
- Stage IIIC Anal Cancer
- Stage IIIB Anal Cancer
- Unresectable Anal Squamous Cell Carcinoma
- Stage III Anal Cancer
- Stage IV Anal Cancer
- Anal Basaloid Carcinoma
- Anal Squamous Cell Carcinoma
- Anal Canal Cloacogenic Carcinoma
Video Summary
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: Up to 2 years
Year 2
Overall survival
Up to 2 years
Incidence of adverse events
Objective response rate (ORR)
Progression-free survival
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Arm A (carboplatin, paclitaxel)
1 of 2
Arm B (carboplatin, paclitaxel, nivolumab)
1 of 2
Active Control
Experimental Treatment
205 Total Participants · 2 Treatment Groups
Primary Treatment: Paclitaxel · No Placebo Group · Phase 3
Arm B (carboplatin, paclitaxel, nivolumab)Experimental Group · 3 Interventions: Paclitaxel, Nivolumab, Carboplatin · Intervention Types: Drug, Biological, Drug
Arm A (carboplatin, paclitaxel)ActiveComparator Group · 2 Interventions: Paclitaxel, Carboplatin · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Nivolumab
FDA approved
Carboplatin
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,084 Previous Clinical Trials
41,141,439 Total Patients Enrolled
Cathy EngPrincipal InvestigatorECOG-ACRIN Cancer Research Group
3 Previous Clinical Trials
238 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a hemoglobin level of at least 9 g/dL for males and at least 9 g/dL for females.
You have inoperable, recurrent, or metastatic disease not amenable to curative therapy.
Patient must have histological or cytological confirmation of anal squamous cell carcinoma (includes basaloid and cloacogenic lesions) from the primary tumor or a newly diagnosed recurrent/metastatic lesion.
You are eligible if you are at least 18 years of age.
Patient must have Eastern Cooperative Oncology Group (ECOG) performance status =< 0-1.
Patients must have measurable disease according to RECIST criteria version 1.1 and based on radiologic assessment performed < 4 weeks prior to randomization.
Patients with untreated brain metastases are eligible if they are asymptomatic and if treatment ended > 3 months prior to randomization.
You have a neutrophil count of at least 1,500/mcL.
Who else is applying?
What state do they live in?
| Florida | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Kaiser Permanente-San Francisco | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 50.0% |
| Did not meet criteria | 50.0% |
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Conditions
Cancer Related
Treatments