Active not recruiting

A Study of Anti-PD-L1 Checkpoint Antibody (LY3300054) Alone and in Combination in Participants With Advanced Refractory Solid Tumors (PACT)

I8J-MC-JYCA - ClinicalTrials.gov - NCT02791334

The main purpose of this study is to evaluate the safety and tolerability of anti-programmed cell death ligand 1 (PD-L1) checkpoint antibody LY3300054 in participants with advanced refractory solid tumors.
How long will I be in the trial?
The duration of your participation will depend on the duration of your study treatment, your disease progression, and follow-up visits
Email
Active not recruiting

A Study of Anti-PD-L1 Checkpoint Antibody (LY3300054) Alone and in Combination in Participants With Advanced Refractory Solid Tumors (PACT)

I8J-MC-JYCA - ClinicalTrials.gov - NCT02791334

The main purpose of this study is to evaluate the safety and tolerability of anti-programmed cell death ligand 1 (PD-L1) checkpoint antibody LY3300054 in participants with advanced refractory solid tumors.
How long will I be in the trial?
The duration of your participation will depend on the duration of your study treatment, your disease progression, and follow-up visits
Email

Key Requirements

Age :

18+

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

Participants must

Participant must have diagnosis of advanced solid tumor confirmed by histology or cytology - Participants entering the Phase 1a dose escalation must submit, if available, an archival tumor tissue sample

Participants participating ONLY in the Phase 1b expansion must submit tissue sample from either a newly obtained core or excisional biopsy of a tumor lesion or a recent (≤3 years since last documented progression of disease.) biopsy

Participants must NOT

Participant must not have a serious concomitant systemic disorder including HIV, active hepatitis B virus (HBV), active hepatitis C virus (HCV), active autoimmune disorder or disease requiring high dose of steroids

Participant must not have a bowel obstruction or chronic diarrhea

Participant must not have symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment

Participant must not have received a live vaccine within 30 days before the first dose of study treatment

Trial Summary

Conditions the trial is for

Solid Tumor, Lung Cancer

What the trial is testing?

LY3300054, Ramucirumab, Abemaciclib, Merestinib

Could I receive a Placebo?

no

Enrollment Goal

215

Trial Dates

June 2016 - December 2021

Trial Phase

1

Enter your postal code to find the nearest site

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

Participants must

Participant must have diagnosis of advanced solid tumor confirmed by histology or cytology - Participants entering the Phase 1a dose escalation must submit, if available, an archival tumor tissue sample

Participants participating ONLY in the Phase 1b expansion must submit tissue sample from either a newly obtained core or excisional biopsy of a tumor lesion or a recent (≤3 years since last documented progression of disease.) biopsy

Participants must NOT

Participant must not have a serious concomitant systemic disorder including HIV, active hepatitis B virus (HBV), active hepatitis C virus (HCV), active autoimmune disorder or disease requiring high dose of steroids

Participant must not have a bowel obstruction or chronic diarrhea

Participant must not have symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment

Participant must not have received a live vaccine within 30 days before the first dose of study treatment

Trial Summary

Conditions the trial is for

Solid Tumor, Lung Cancer

What the trial is testing?

LY3300054, Ramucirumab, Abemaciclib, Merestinib

Could I receive a Placebo?

no

Enrollment Goal

215

Trial Dates

June 2016 - December 2021

Trial Phase

1

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Trial Locations

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Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?