Advanced CancerPhase 1/2NCT04158700
A Study of LY3200882 and Pembrolizumab in Participants With Advanced Cancer
A Phase 1/2 study testing LY3200882 and Pembrolizumab in people with Advanced Cancer, run by Eli Lilly and Company at 6 sites in 3 countries.
Trial summary
The main purpose of this study is to see if the drug LY3200882 which is an inhibitor of transforming growth factor-β (TGFβ) receptor 1 in combination with pembrolizumab is safe and effective in participants with cancer that has spread to other parts of the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- LY3200882 and Pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 5 Dec 2019to 11 May 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have received a PD-1 PDLI therapy within 9 weeks of starting dosing on this study [for example, nivolumab, pembrolizumab, atezolizumab]
- Participants must be willing to have tumor biopsies
- Participants must have adequate organ function
- Participants must have Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
- Participants must be able to swallow tablets
- Participants with stable, previously treated brain metastases may participate if neurologic symptoms have resolved and participants have been off steroids for at least 14 days
Who cannot join
- Participants must not have moderate or severe cardiovascular disease
- Participants must not have active autoimmune disease (for example Crohn's disease, Hashimotos disease, etc)
- Participants must not have an active infection requiring treatment
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Spain3 sites
Hospital Clinic I Provincial
Barcelona, 08036
Institut Catala d'Oncologia
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Madrid Norte Sanchinarro
Madrid, 28050
France2 sites
CHU de Besancon Hopital Jean Minjoz
Besançon, 25030
Gustave Roussy
Villejuif, 94805
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Phase 1b/2 Study of LY3200882 and Pembrolizumab in Patients With Advanced Cancer
The main purpose of this study is to see if the drug LY3200882 which is an inhibitor of transforming growth factor-β (TGFβ) receptor 1 in combination with pembrolizumab is safe and effective in participants with cancer that has spread to other parts of the body.
- Conditions
- Advanced Cancer
- Being tested
- LY3200882, Pembrolizumab
- Keywords
- TGF-beta, Urothelial carcinoma, Hepatocellular carcinoma, Non-small cell lung cancer, TGF- beta receptor type I inhibitor
- Medical subject headings
- Camurati-Engelmann Syndrome, Carcinoma, Transitional Cell, Carcinoma, Hepatocellular, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3200882Drug
LY3200882 administered orally
PembrolizumabDrug
Pembrolizumab administered IV
| Study group | Role | What they receive |
|---|---|---|
| LY3200882 and Pembrolizumab (Dose Level 1) | Experimental | Participants with urothelial carcinoma: LY3200882 administered orally with pembrolizumab administered intravenously (IV). Receives: Drug: LY3200882; Drug: Pembrolizumab |
| LY3200882 and Pembrolizumab (Dose Level 2) | Experimental | Participants with urothelial carcinoma: LY3200882 administered orally with pembrolizumab administered IV. Receives: Drug: LY3200882; Drug: Pembrolizumab |
| LY3200882 and Pembrolizumab Expansion | Experimental | Participants with urothelial carcinoma, non-small cell lung cancer, or hepatocellular carcinoma: LY3200882 administered orally twice in combination with pembrolizumab administered IV. Receives: Drug: LY3200882; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose Limiting Toxicity (DLT)
Number of Participants with DLT
Measured: Up to 6 Weeks
Secondary outcomes (3)
Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR)
ORR: Percentage of Participants with CR or PR
Measured: Baseline through Disease Progression or Death (Estimated at up to 12 Months)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3200882 in Combination With Pembrolizumab
PK: Cmax of LY3200882 in Combination With Pembrolizumab
Measured: Baseline through Week 13
Duration of Response (DoR)
DoR
Measured: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated at up to 12 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start5 Dec 2019 (estimated)
- Primary completion11 May 2023 (estimated)
- Study completion11 May 2023 (estimated)
Why it stopped: The withdrawal is due to a strategic realignment and is not related to any particular safety or efficacy concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158700
- Sponsor's protocol ID
- 17387
- Other IDs
- I8X-MC-JECD, 2019-001156-18, KEYNOTE-961, 2019
- Status last verified
- Feb 2020
- First submitted
- 7 Nov 2019
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b/2 Study of LY3200882 and Pembrolizumab in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT04158700
- Acronym / sponsor ID
- 17387
- Conditions
- Advanced Cancer
- Keywords
- TGF-beta, Urothelial carcinoma, Hepatocellular carcinoma, Non-small cell lung cancer, TGF- beta receptor type I inhibitor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The withdrawal is due to a strategic realignment and is not related to any particular safety or efficacy concern.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 5 Dec 2019 (estimated)
- Primary completion
- 11 May 2023 (estimated)
- Study completion
- 11 May 2023 (estimated)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to see if the drug LY3200882 which is an inhibitor of transforming growth factor-β (TGFβ) receptor 1 in combination with pembrolizumab is safe and effective in participants with cancer that has spread to other parts of the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LY3200882 and Pembrolizumab (Dose Level 1) | Experimental | Drug: LY3200882, Drug: PembrolizumabParticipants with urothelial carcinoma: LY3200882 administered orally with pembrolizumab administered intravenously (IV). |
| LY3200882 and Pembrolizumab (Dose Level 2) | Experimental | Drug: LY3200882, Drug: PembrolizumabParticipants with urothelial carcinoma: LY3200882 administered orally with pembrolizumab administered IV. |
| LY3200882 and Pembrolizumab Expansion | Experimental | Drug: LY3200882, Drug: PembrolizumabParticipants with urothelial carcinoma, non-small cell lung cancer, or hepatocellular carcinoma: LY3200882 administered orally twice in combination with pembrolizumab administered IV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must have received a PD-1 PDLI therapy within 9 weeks of starting dosing on this study [for example, nivolumab, pembrolizumab, atezolizumab]
- Participants must be willing to have tumor biopsies
- Participants must have adequate organ function
- Participants must have Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
- Participants must be able to swallow tablets
Key exclusion criteria (3 listed)
- Participants must not have moderate or severe cardiovascular disease
- Participants must not have active autoimmune disease (for example Crohn's disease, Hashimotos disease, etc)
- Participants must not have an active infection requiring treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3200882LY3200882 administered orally | Drug | LY3200882 and Pembrolizumab (Dose Level 1), LY3200882 and Pembrolizumab (Dose Level 2), LY3200882 and Pembrolizumab Expansion |
| PembrolizumabPembrolizumab administered IV | Drug | LY3200882 and Pembrolizumab (Dose Level 1), LY3200882 and Pembrolizumab (Dose Level 2), LY3200882 and Pembrolizumab Expansion |
Primary outcome
Number of Participants with Dose Limiting Toxicity (DLT)
Time frame: Up to 6 Weeks
Number of Participants with DLT
3 secondary outcomes
Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR)
Time frame: Baseline through Disease Progression or Death (Estimated at up to 12 Months)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3200882 in Combination With Pembrolizumab
Time frame: Baseline through Week 13
Duration of Response (DoR)
Time frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated at up to 12 Months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- A Study of LY3200882 and Pembrolizumab in Participants With Advanced CancerLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LY3200882 and Pembrolizumab in people with Advanced Cancer, run by Eli Lilly and Company at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain, France, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose Limiting Toxicity (DLT) (time frame: Up to 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.