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PD-L1 Inhibitor

Anti-PD-L1 Checkpoint Antibody (LY3300054) for Solid Tumors (PACT Trial)

Phase 1

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For Phase 1b LY3300054 monotherapy or combination therapy, no prior treatment with a PD-1 or PD-L1 agent is allowed.

For LY3300054 + LY3321367 in PD-1/PD-L1- resistant/refractory, MSI-H/MMR-deficient advanced solid tumors:

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to measured progressive disease or death (approximately 12 months)

Awards & highlights

PACT Trial Summary

This trial is testing a new cancer treatment to see if it is safe and effective.

Who is the study for?

This trial is for adults with advanced solid tumors that are resistant to standard treatments. Eligible participants include those with specific types of breast, pancreatic, and skin cancers, among others. They must have measurable disease, adequate organ function, an ECOG performance status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory), and a life expectancy over 12 weeks. Prior immunotherapy is allowed under certain conditions.Check my eligibility

What is being tested?

The study tests the safety and effects of LY3300054 alone or combined with other drugs like Ramucirumab, Abemaciclib, LY3321367, and Merestinib on various advanced solid tumors. It aims to find out how well these treatments work against cancer that hasn't responded to previous therapies.See study design

What are the potential side effects?

Potential side effects may include immune-related reactions affecting different organs which could lead to inflammation symptoms such as fatigue or digestive issues; infusion reactions during drug administration; increased risk of infections due to immune system suppression; liver enzyme changes; blood disorders.

PACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never been treated with PD-1 or PD-L1 inhibitors.

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My cancer is advanced, does not respond to PD-1/PD-L1 treatments, and has high microsatellite instability or is MMR-deficient.

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I have never stopped an immunotherapy treatment due to severe side effects.

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My cancer is confirmed as advanced through tissue analysis.

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I do not have liver metastases and my liver function tests are normal.

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My breast cancer does not show high levels of HER2.

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My breast cancer is hormone receptor positive.

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I've had 1 to 3 chemotherapy treatments for my cancer after it spread.

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My diagnosis is advanced or metastatic pancreatic cancer, not including other types of pancreatic tumors.

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I have at least one tumor that can be measured by standard medical imaging.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My condition worsened or didn't respond well to up to 2 treatments.

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I have been treated with a PD-1/PD-L1 inhibitor before.

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I haven't had severe side effects from previous immunotherapy.

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My advanced cancer is confirmed to be MSI-H or MMR-deficient.

Select...

My liver function tests are within normal limits.

PACT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to measured progressive disease or death (approximately 12 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to measured progressive disease or death (approximately 12 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to measured progressive disease or death (approximately 12 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with LY3300054 Dose Limiting Toxicities (DLTs)

Secondary outcome measures

Chromium

Duration of Response (DoR)

Objective Response Rate (ORR): Proportion of Participants With a Complete Response (CR) or Partial Response (PR)

+7 more

PACT Trial Design

12Treatment groups

Experimental Treatment

Group I: LY3300054 Expansion (Metastatic Cutaneous Melanoma)Experimental Treatment1 Intervention

LY3300054 given IV on day 1 and day 15 of a 28 day cycle.

Group II: LY3300054 Expansion (MSI-H Solid Tumors)Experimental Treatment1 Intervention

LY3300054 given IV on day 1 and day 15 of a 28 day cycle.

Group III: LY3300054 + RamucirumabExperimental Treatment2 Interventions

LY3300054 and ramucirumab given IV on day 1 and day 15 of a 28 day cycle or ramucirumab given IV on day 1 and day 8 and LY3300054 given IV on day 1 of a 21 day cycle.

Group IV: LY3300054 + Merestinib (Pancreatic Cancer) ExpansionExperimental Treatment2 Interventions

LY3300054 given IV on day 1 and day 15 and merestinib given orally once daily of a 28 day cycle.

Group V: LY3300054 + MerestinibExperimental Treatment2 Interventions

LY3300054 given IV on day 1 and day 15 and merestinib given orally once daily of a 28 day cycle.

Group VI: LY3300054 + LY3321367 Expansion (PD-1/PD-L1 Naïve, MSI-H)Experimental Treatment2 Interventions

LY3300054 and LY3321367 given IV on day 1 and day 15 of a 28 day cycle.

Group VII: LY3300054 + LY3321367 ExpansionExperimental Treatment2 Interventions

LY3300054 and LY3321367 given IV on day 1 and day 15 of a 28 day cycle.

Group VIII: LY3300054 + Abemaciclib (Concurrent Dosing)Experimental Treatment2 Interventions

LY3300054 given IV on day 1 and day 15 and abemaciclib given orally every 12 hours of a 28 day cycle.

Group IX: LY3300054 + AbemaciclibExperimental Treatment2 Interventions

LY3300054 given IV on day 1 and day 15 and abemaciclib given orally every 12 hours of a 28 day cycle. This arm will only be initiated if required.

Group X: LY3300054Experimental Treatment1 Intervention

LY3300054 given intravenously (IV) on day 1 and day 15 of a 28 day cycle or LY3300054 given IV on day 1 of a 21 (or 28) day cycle.

Group XI: Abemaciclib + LY3300054Experimental Treatment2 Interventions

LY3300054 given IV on day 1 and day 15 and abemaciclib given orally every 12 hours of a 28 day cycle.

Group XII: : LY3300054 + Abemaciclib (HR+, HER2- Breast Cancer) ExpansionExperimental Treatment2 Interventions

LY3300054 given IV on day 1 and day 15 and abemaciclib given orally every 12 hours of a 28 day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LY3300054

2017

Completed Phase 1

~230

Ramucirumab

2017

Completed Phase 3

~5050

Abemaciclib

2019

Completed Phase 2

~1710

LY3321367

2017

Completed Phase 1

~210

Merestinib

2017

Completed Phase 1

~90

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,613 Previous Clinical Trials

3,200,714 Total Patients Enrolled

Study DirectorEli Lilly and Company

1,344 Previous Clinical Trials

405,037 Total Patients Enrolled

Media Library

Skin Cancer Research Study Groups: LY3300054, LY3300054 + Ramucirumab, Abemaciclib + LY3300054, LY3300054 + Abemaciclib (Concurrent Dosing), LY3300054 + Abemaciclib, LY3300054 + Merestinib, LY3300054 Expansion (Metastatic Cutaneous Melanoma), LY3300054 Expansion (MSI-H Solid Tumors), : LY3300054 + Abemaciclib (HR+, HER2- Breast Cancer) Expansion, LY3300054 + LY3321367 Expansion (PD-1/PD-L1 Naïve, MSI-H), LY3300054 + LY3321367 Expansion, LY3300054 + Merestinib (Pancreatic Cancer) Expansion

Skin Cancer Clinical Trial 2023: LY3300054 Highlights & Side Effects. Trial Name: NCT02791334 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medicinal benefits has LY3300054 been found to provide?

"Non-small cell lung carcinoma is typically managed with the drug LY3300054. This medication can also prove efficacious against conditions such as disease, elevated risk of relapse, and adenocarcinoma."

Answered by AI

Is this experimental procedure unique to the medical field?

"LY3300054 has been under medical observation since 2009, when Eli Lilly and Company first sponsored a clinical trial with 220 participants. Subsequent trials resulted in Phase 1 approval for the drug, leading to 140 current studies located across 43 nations and 1584 cities."

Answered by AI

Are there presently any opportunities for individuals to join this clinical experiment?

"As indicated on clinicaltrials.gov, the research team is not actively seeking participants at this time; however, they posted it in June 2016 and updated it as recently as November 2022. Fortunately, there are 3118 other medical studies accepting new enrolment currently."

Answered by AI

To what extent is LY3300054 a safe option for individuals?

"Assessing the safety of LY3300054, our team at Power judged it to be a 1 since this is merely a Phase 1 trial. This means there's only limited evidence that supports its efficacy and safety."

Answered by AI

Are there any other investigations which have utilized LY3300054?

"Currently, 140 scientific trials are actively examining the effects of LY3300054 with 24 within Phase 3. Of those studies, most can be found in Alicante and Pamplona/Iruña; however, globally there are 8502 study sites dedicated to this topic."

Answered by AI

What is the total number of participants enrolled in this experiment?

"This clinical trial has concluded its recruitment phase; it was first posted on June 29th 2016, and the most recent modification took place November 22nd 2022. However, if you are looking for other relevant studies, presently there are 2,978 searches actively seeking patients with microsatellite-instability high (msi-h) solid tumors and 140 trials that require participants to take part in a study of LY3300054."

Answered by AI

From how many sites can this clinical experiment be accessed?

"At present, 5 medical centres are participating in this trial; these include Nashville, Houston and Toronto. For patient convenience, it is encouraged to select the nearest location to minimize travel needs."

Answered by AI