Discontinue PD-1/PD-L1-1 inhibitor for Melanoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Melanoma+12 MoreDiscontinue PD-1/PD-L1-1 inhibitor - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study whether it is better to stop treatment with PD-1/PD-L1 therapy after one year or continue until disease progression.

Eligible Conditions
  • Bladder Cancer
  • Cervical Cancer
  • Advanced Solid Tumors
  • Melanoma
  • Non-Small Cell Lung Cancer
  • Bile Duct Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Colorectal Cancer
  • Liver Cancer
  • Kidney Cancer
  • Anal Cancer
  • Stomach Cancer
  • Cutaneous Neuroendocrine Carcinoma

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

4 Primary · 3 Secondary · Reporting Duration: Between 4 months and 7.9 months

Month 9
Progression-free Survival (PFS) (at between 2-3.9 months)
Month 9
Progression-free Survival (PFS) (at between 4-7.9 months)
Up to 36 months
Best Objective Response (BOR)
Incidence of irAEs (Immune-Related Adverse Events)
Overall Survival (OS)
Progression-free Survival (PFS)
Time to next treatment

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Continue Treatment with PD-1/PD-L1 inhibitor
1 of 2
Discontinue Treatment with PD-1/PD-L1-1 inhibitor
1 of 2

Active Control

Experimental Treatment

578 Total Participants · 2 Treatment Groups

Primary Treatment: Discontinue PD-1/PD-L1-1 inhibitor · No Placebo Group · Phase 3

Discontinue Treatment with PD-1/PD-L1-1 inhibitor
Other
Experimental Group · 1 Intervention: Discontinue PD-1/PD-L1-1 inhibitor · Intervention Types: Other
Continue Treatment with PD-1/PD-L1 inhibitor
Drug
ActiveComparator Group · 1 Intervention: Continue PD-1/PD-L1 Inhibitors treatment · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: between 4 months and 7.9 months

Who is running the clinical trial?

Antoinette J WozniakLead Sponsor
Antoinette J Wozniak, MDLead Sponsor
Antoinette J Wozniak, MD, FACP2.33 ReviewsPrincipal Investigator - UPMC Hillman Cancer Center
University of Pittsburgh
1Patient Review
The neglectful care I received resulted in death.

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
All patients must have an advanced, malignant solid tumor (such as NSCLC, bladder, HNSCC, renal, melanoma, cervical Merkel cell and MMR/MSI cancers including colon, rectal cholangio esophageal ovarian uterine anal gastric GE junction hepatocellular and triple negative breast cancer) that is being treated with a PD-1/PD-L1 inhibitor (including pembrolizumab nivolumab atezolizumab durvalumab or avelumab) in accordance to standard care.
Qualified participants have already initiated a course of treatment with chemotherapy, ipilimumab or another PD-1/PD-L1 inhibitor.
Patients must have a sustained degree of wellness as demonstrated by imaging tests taken within 6 weeks of beginning the study.
You have given permission to be randomized into either a group that ceases immunotherapy treatment within one year plus or minus six weeks, or a group that continues the same therapy beyond this timeline.
Patients must have either measurable or non-quantifiable disease according to iRECIST standards.
Participation in a clinical trial is not allowed.