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A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab (PAVE-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03409458
Recruitment Status : Active, not recruiting
First Posted : January 24, 2018
Last Update Posted : April 26, 2022
Sponsor:
Collaborators:
Pfizer
EMD Serono
Information provided by (Responsible Party):
Promontory Therapeutics Inc.

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer (NSCLC) Drug: PT-112 Biological: avelumab Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2a Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab
Actual Study Start Date : April 24, 2018
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Avelumab

Arm Intervention/treatment
Experimental: PT-112 in combination with avelumab

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.

Drug: PT-112

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.


Biological: avelumab
Avelumab will be administered at a fixed dose of 800 mg on Days 1 and 15.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. NSCLC Cohort: Confirm the RP2D patients with metastatic or locally advanced, squamous or non-squamous NSCLC [ Time Frame: 24 months ]
  2. NSCLC Cohort: Assess the safety profile of PT-112 in combination with avelumab [ Time Frame: 24 months ]
  3. 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 ]
  4. 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 ]
  5. NSCLC Cohort: Evaluate median duration of response among responding patients [ Time Frame: 24 months ]
  6. NSCLC Cohort: Evaluate median PFS [ Time Frame: 24 months ]
  7. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. 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;
  2. Must provide study-related tumor specimens;
  3. ECOG(PS) 0-1;
  4. Estimated Life Expectancy > 3 months;
  5. Adequate bone marrow (BM), renal, hepatic and metabolic function.

Key Exclusion Criteria:

  1. 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;
  2. Known symptomatic central nervous system (CNS) metastases requiring steroids.
  3. Diagnosis of any other malignancy within 2 years prior to enrollment;
  4. Vaccination within 4 weeks of the first dose of study treatment is prohibited except for administration of inactivated vaccines;
  5. Current use of immunosuppressive medication at study entry;
  6. Active or prior autoimmune disease that might deteriorate with receiving an immunostimulatory agent;
  7. Acute or chronic infections requiring systemic therapy;
  8. Known history of autoimmune colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis;
  9. Known intolerance to checkpoint inhibitor therapy, defined by the occurrence of an AE leading to drug discontinuation;
  10. Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409458


Locations
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United States, Arizona
Arizona
Phoenix, Arizona, United States, 85054
United States, Colorado
Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Florida
Jacksonville, Florida, United States, 32224
United States, Minnesota
Minnesota
Rochester, Minnesota, United States, 55905
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Switzerland
Lausanne
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Promontory Therapeutics Inc.
Pfizer
EMD Serono
Investigators
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Principal Investigator: Daniel D Karp, MD M.D. Anderson Cancer Center
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Responsible Party: Promontory Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03409458    
Other Study ID Numbers: PT-112-103-PAVE-1
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: April 26, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Promontory Therapeutics Inc.:
Advanced Solid Tumors
NSCLC
Non-small cell lung cancer
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Avelumab
Antineoplastic Agents, Immunological
Antineoplastic Agents