Non-Small Cell Lung Cancer (NSCLC)Phase 1/2PAVE-1NCT03409458
A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab
A Phase 1/2 study testing PT-112 and avelumab in people with Non-Small Cell Lung Cancer (NSCLC), run by Promontory Therapeutics Inc. at 6 sites in 2 countries.
Trial summary
This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study of PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer (NSCLC)
- What is being tested?
- PT-112 and avelumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 24 Apr 2018to 31 Aug 2022
- 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
- Histologically or cytologically confirmed metastatic or locally advanced, squamous or non-squamous NSCLC (NSCLC). Patients must have received no more than four prior lines of therapy, including a PD-1 / PD-L1-containing therapy and a platinum containing regimen. Patients must have received no more than one taxane containing regimen and no more than one investigational agent;
- Must provide study-related tumor specimens;
- ECOG(PS) 0-1;
- Estimated Life Expectancy > 3 months;
- Adequate bone marrow (BM), renal, hepatic and metabolic function.
Who cannot join
- Concurrent cancer treatment with cytoreductive therapy, radiotherapy, cytokine therapy, cytotoxic agents, targeted small molecule therapy or any investigational anticancer small molecule drugs within 2 weeks prior to the start of study treatment (except 5 weeks from last dose of nitrosourea compound) OR treatment with monoclonal antibodies within 4 weeks prior to the start of study treatment;
- Known symptomatic central nervous system (CNS) metastases requiring steroids.
- Diagnosis of any other malignancy within 2 years prior to enrollment;
- Vaccination within 4 weeks of the first dose of study treatment is prohibited except for administration of inactivated vaccines;
- Current use of immunosuppressive medication at study entry;
- Active or prior autoimmune disease that might deteriorate with receiving an immunostimulatory agent;
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- Acute or chronic infections requiring systemic therapy;
- Known history of autoimmune colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis;
- Known intolerance to checkpoint inhibitor therapy, defined by the occurrence of an AE leading to drug discontinuation;
- Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Colorado
Aurora, Colorado, 80045
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Florida
Jacksonville, Florida, 32224
Arizona
Phoenix, Arizona, 85054
Minnesota
Rochester, Minnesota, 55905
About this study
Official title: A Phase 1b/2a Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab
This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study of PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid tumors.
The study is to be conducted in two parts: the Dose Escalation Phase of PT-112 within the combination and the Dose Confirmation Phase in patients with non-small cell lung cancer who will be treated at the RP2D.
Read the detailed description
This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study of PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid tumors. The study is to be conducted in two parts: the Dose Escalation Phase and the Dose Confirmation Phase.
Enrollment for dose escalation and dose confirmation is complete.
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Being tested
- PT-112, avelumab
- Keywords
- Advanced Solid Tumors, NSCLC, Non-small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PT-112Drug
The RP2D of PT-112 when used in combination with avelumab has been determined during dose escalation and is being confirmed in the NSCLC dose confirmation cohort.
For the NSCLC confirmation cohort, PT-112 will be administered at a dose of 360 mg/m2 on Days 1, 8 and 15.
avelumabBiological
Avelumab will be administered at a fixed dose of 800 mg on Days 1 and 15.
| Study group | Role | What they receive |
|---|---|---|
| PT-112 in combination with avelumab | Experimental | PT-112, administered by intravenous infusion avelumab, administered by intravenous infusion
Patients with all listed conditions are eligible for treatment during the dose escalation phase of the study. Patients with NSCLC are eligible for the dose confirmation phase of the study. Receives: Drug: PT-112; Biological: avelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
NSCLC Cohort: Evaluate best overall response rate (ORR) by tumor type according to Immune-Response Criteria (iRECIST) in metastatic or locally advanced, squamous or non-squamous NSCLC.
Measured: 24 months
Secondary outcomes (7)
NSCLC Cohort: Confirm the RP2D patients with metastatic or locally advanced, squamous or non-squamous NSCLC
Measured: 24 months
NSCLC Cohort: Assess the safety profile of PT-112 in combination with avelumab
Measured: 24 months
NSCLC Cohort: Evaluate disease control rate (CR, PR and SD lasting ≥6 months) overall and by tumor type based on iRECIST
Measured: 24 months
NSCLC Cohort: Evaluate disease control rate (CR, PR and SD lasting ≥3 months) overall and by tumor type based on iRECIST
Measured: 24 months
NSCLC Cohort: Evaluate median duration of response among responding patients
Measured: 24 months
NSCLC Cohort: Evaluate median PFS
Measured: 24 months
NSCLC Cohort: Evaluate PFS rate at 6 months from start of study drug, based on tumor assessments every 8 weeks based on iRECIST
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start24 Apr 2018
- Primary completion1 Jun 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Promontory Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer, EMD Serono
- Responsible party
- Sponsor
- Investigators
- Daniel D Karp, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409458
- Sponsor's protocol ID
- PT-112-103-PAVE-1
- Acronym
- PAVE-1
- Status last verified
- Nov 2023
- First submitted
- 18 Jan 2018
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2a Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab
- ClinicalTrials.gov ID
- NCT03409458
- Acronym / sponsor ID
- PAVE-1 / PT-112-103-PAVE-1
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Keywords
- Advanced Solid Tumors, NSCLC, Non-small cell lung cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Promontory Therapeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pfizer, EMD Serono
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 24 Jan 2018 (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.
This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study of PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid tumors.
The study is to be conducted in two parts: the Dose Escalation Phase of PT-112 within the combination and the Dose Confirmation Phase in patients with non-small cell lung cancer who will be treated at the RP2D.
Detailed description
This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study of PT-112 in combination with the anti-PD-L1 antibody, avelumab, in selected advanced solid tumors. The study is to be conducted in two parts: the Dose Escalation Phase and the Dose Confirmation Phase.
Enrollment for dose escalation and dose confirmation is complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PT-112 in combination with avelumab | Experimental | Drug: PT-112, Biological: avelumabPT-112, administered by intravenous infusion avelumab, administered by intravenous infusion Patients with all listed conditions are eligible for treatment during the dose escalation phase of the study. Patients with NSCLC are eligible for the dose confirmation phase of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed metastatic or locally advanced, squamous or non-squamous NSCLC (NSCLC). Patients must have received no more than four prior lines of therapy, including a PD-1 / PD-L1-containing therapy and a platinum containing regimen. Patients must have received no more than one taxane containing regimen and no more than one investigational agent;
- Must provide study-related tumor specimens;
- ECOG(PS) 0-1;
- Estimated Life Expectancy > 3 months;
- Adequate bone marrow (BM), renal, hepatic and metabolic function.
Key exclusion criteria (10 listed)
- Concurrent cancer treatment with cytoreductive therapy, radiotherapy, cytokine therapy, cytotoxic agents, targeted small molecule therapy or any investigational anticancer small molecule drugs within 2 weeks prior to the start of study treatment (except 5 weeks from last dose of nitrosourea compound) OR treatment with monoclonal antibodies within 4 weeks prior to the start of study treatment;
- Known symptomatic central nervous system (CNS) metastases requiring steroids.
- Diagnosis of any other malignancy within 2 years prior to enrollment;
- Vaccination within 4 weeks of the first dose of study treatment is prohibited except for administration of inactivated vaccines;
- Current use of immunosuppressive medication at study entry;
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 |
|---|---|---|
| PT-112The RP2D of PT-112 when used in combination with avelumab has been determined during dose escalation and is being confirmed in the NSCLC dose confirmation cohort. For the NSCLC confirmation cohort, PT-112 will be administered at a dose of 360 mg/m2 on Days 1, 8 and 15. | Drug | PT-112 in combination with avelumab |
| avelumabAvelumab will be administered at a fixed dose of 800 mg on Days 1 and 15. | Biological | PT-112 in combination with avelumab |
Primary outcome
NSCLC Cohort: Evaluate best overall response rate (ORR) by tumor type according to Immune-Response Criteria (iRECIST) in metastatic or locally advanced, squamous or non-squamous NSCLC.
Time frame: 24 months
7 secondary outcomes
NSCLC Cohort: Confirm the RP2D patients with metastatic or locally advanced, squamous or non-squamous NSCLC
Time frame: 24 months
NSCLC Cohort: Assess the safety profile of PT-112 in combination with avelumab
Time frame: 24 months
NSCLC Cohort: Evaluate disease control rate (CR, PR and SD lasting ≥6 months) overall and by tumor type based on iRECIST
Time frame: 24 months
NSCLC Cohort: Evaluate disease control rate (CR, PR and SD lasting ≥3 months) overall and by tumor type based on iRECIST
Time frame: 24 months
NSCLC Cohort: Evaluate median duration of response among responding patients
Time frame: 24 months
NSCLC Cohort: Evaluate median PFS
Time frame: 24 months
NSCLC Cohort: Evaluate PFS rate at 6 months from start of study drug, based on tumor assessments every 8 weeks based on iRECIST
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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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.
Daniel D Karp, MD principal investigator
M.D. Anderson Cancer Center
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PT-112 and avelumab in people with Non-Small Cell Lung Cancer (NSCLC), run by Promontory Therapeutics Inc. at 6 sites in 2 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 18 Nov 2023. 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 United States, Switzerland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
NSCLC Cohort: Evaluate best overall response rate (ORR) by tumor type according to Immune-Response Criteria (iRECIST) in metastatic or locally advanced, squamous or non-squamous NSCLC. (time frame: 24 months). 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 18 Nov 2023.