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Pancreatic CancerPhase 2NCT03023722

Phase II Anetumab Ravtansine in Pre-treated Mesothelin-expressing Pancreatic Cancer

A Phase 2 study testing anetumab ravtansine in people with Pancreatic Cancer, run by Yale University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to: -Test the activity/response rate per RECIST 1.1 criteria of anetumab ravtansine in patients with advanced pancreatic cancer who stain for mesothelin expression The secondary objectives of this study are to: Time to Progression (TTP) defined as time from study treatment to… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
anetumab ravtansine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
3 sitesUnited States
Study dates
11 May 2017to 11 Dec 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Eligibility criteria for prescreening
  • Must have had at least one and not more than two prior chemotherapy regimens for advanced disease (neoadjuvant or adjuvant chemotherapy would not be counted as a line of therapy). If prior radiation, measurable lesion outside radiation portal.
  • Written informed consent for prescreening.
  • Unresectable locally advanced or metastatic pancreatic cancer, confirmed by histology
  • Availability of archival or fresh tissue for testing of mesothelin expression level.
  • Note: Archival tissue is preferred and fresh biopsy should only be obtained if no archival tissue is available and if in the investigator's judgement, there is no additional risk for the patient's safety. Patients with a sarcomatoid histology are not expected to have mesothelin overexpression and should not enter prescreening.
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  • Age ≥ 18 years.
  • Life expectancy of at least 3 months.
  • No prior treatment with anetumab ravtansine (or any other mesothelin-based therapy)
  • Eligibility criteria for full study
  • Written informed consent for full study.
  • Histological documentation of overexpressing mesothelin at the moderate (2+) or stronger (3+) level in at least 30% of tumor cells as determined by IHC.
  • Unresectable locally advanced or metastatic pancreatic cancer
  • At least one but not more than two prior chemotherapy regimens with progression or documented intolerance (neoadjuvant or adjuvant chemotherapy would not be counted as a line of therapy).
  • Patients must have at least 1 measurable lesion according to RECIST v 1.1
  • ECOG PS of 0 or 1
  • Life expectancy of at least 3 months.
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements conducted within 7 days before starting study treatment:
  • Total bilirubin ≤ 1.5 x the upper limit of normal (ULN). Documented Gilbert syndrome is allowed if total bilirubin is mildly elevated (< 6 mg/dL).
  • ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer).
  • ALP limit ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer).
  • Extent of baseline tumor burden will not interfere with causal assessment of treatment-emergent hepatotoxicity, at the investigator's discretion.
  • Amylase and lipase ≤ 1.5 x ULN.
  • Glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease (MDRD) abbreviated formula (see Appendix 16.6).
  • Adequate coagulation, as assessed by the following laboratory test results:
  • International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN (CTCAE Grade ≤ 1).
  • Partial thromboplastin time (PTT) or activated PTT (aPTT) ≤ 1.5 x ULN (CTCAE Grade ≤ 1).
  • Note: Patients on stable dose of anti-coagulation therapy will be allowed to participate if they have no sign of bleeding or clotting and INR / PT and PTT / aPTT test results are compatible with the acceptable benefit-risk ratio at the investigator's discretion
  • Platelet count ≥ 75,000/mm3 , without platelet transfusion within 3 weeks before the start of study treatment.
  • Hemoglobin (Hb) ≥ 8 g/dL, without blood transfusion or erythropoietin within 6 weeks before the start of study treatment.
  • Note: Patients on stable dose of anti-coagulation therapy will be allowed to participate if they have no sign of bleeding or clotting and INR / PT and PTT / aPTT test results are compatible with the acceptable benefit-risk ratio at the investigator's discretion (see Section 8.1).
  • Absolute neutrophil count (ANC) ≥ 1000/mm3
  • Left ventricular ejection fraction (LVEF) ≥ 50% or the lower limit of normal (LLN) according to local institution ranges of normality

Who cannot join

  • Previous assignment to treatment during this study. Patients permanently withdrawn from study participation will not be allowed to re-enter the study.
  • Previous (within 5 drug half-lives - if drug half-life in subjects is known - or 28 days, whichever is shorter, before the start of study treatment) or concomitant participation in another clinical study with investigational medicinal product(s) (IMP[s]).
  • Patients with corneal epitheliopathy or any eye disorder that may predispose the patients to this condition at the discretion of the investigator.
  • Previous or concurrent cancer that is distinct in primary site or histology within 5 years. Exceptions: curatively treated
  • Cervical cancer in situ.
  • Non-melanoma skin cancer.
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  • Superficial bladder tumors (Non-invasive tumor [Ta], Carcinoma in situ [Tis] and Tumor invades lamina propria [T1]).
  • Major surgery, open biopsy or significant traumatic injury within 28 days before the start of study treatment.
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a serum pregnancy test performed a maximum of 7 days before the start of study treatment, and a negative result must be documented before the start of study treatment.
  • Pre-existing cardiac conditions as outlined below:
  • Congestive heart failure ≥ New York Heart Association (NYHA) class 2.
  • Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before the start of study treatment.
  • Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
  • Clinically significant uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
  • Arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), or venous pulmonary embolism within 6 months before the start of study treatment; venous thrombotic events such as deep vein thrombosis within 3 months before the start of study treatment.
  • Ongoing or active infection (bacterial, fungal, or viral) of NCI-CTCAE version 4.03 Grade > 2.
  • Known history of human immunodeficiency virus (HIV) infection.
  • Known history of chronic hepatitis B or C.
  • Patients with seizure disorder requiring medication.
  • Symptomatic brain metastases or meningeal tumors or other uncontrolled metastases in the central nervous system (CNS) unless the patient
  • Is > 6 months from definitive therapy,
  • Has a negative imaging study within 4 weeks before study entry (ICF signature for full study) and
  • Is clinically stable with respect to the tumor at the time of study entry.
  • History of organ allograft, stem cells or bone marrow transplant.
  • Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event ≥ CTCAE Grade 3 within 4 weeks before the start of study treatment.
  • Non-healing wound, ulcer, or bone fracture.
  • Renal failure requiring peritoneal dialysis or hemodialysis.
  • Known hypersensitivity to anetumab ravtansine, study drug classes or excipients in the formulation.
  • Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study.
  • Unresolved toxicity higher than NCI-CTCAE version 4.03 Grade 1 attributed to any prior therapy/procedure excluding anemia or neuropathy Grade 2 and alopecia of any Grade.
  • Any prohibited prior or concomitant therapy

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901-2163

  • Yale Cancer Center

    New Haven, Connecticut, 06510

Other trials in United States

About this study

Official title: An Open-label, Phase II Study of Intravenous Anetumab Ravtansine (BAY 94-9343), an Anti-mesothelin Antibody Drug Conjugate, in Pretreated Mesothelin-expressing Advanced Pancreatic Cancer

The primary objective of this study is to:

-Test the activity/response rate per RECIST 1.1 criteria of anetumab ravtansine in patients with advanced pancreatic cancer who stain for mesothelin expression

The secondary objectives of this study are to:

  • Time to Progression (TTP) defined as time from study treatment to RECIST 1.1 progression, or death (others going off study will be censored)
  • Toxicity in pancreatic cancer patients (at 6.5 mg/kg dose)
Read the detailed description

This is a non-randomized, open-label, multicenter, Phase II study to evaluate the efficacy and safety of intravenous anetumab ravtansine (BAY 94-9343), an anti-mesothelin antibody drug conjugate, in pretreated mesothelin-expressing advanced pancreatic cancer.

At the time of the start of study treatment, the patients will have pretreated advanced pancreatic cancer that also overexpresses mesothelin as determined by immunohistochemistry (IHC).

A maximum of 30 patients will be enrolled in a minimax, Simon 2-stage design with a single early stopping rule for lack of efficacy. The target population is those patients with pancreatic cancer who have failed an earlier treatment. All patients will be treated with an anti-mesothelin immuno-conjugate, in this single arm, non-randomized trial and all patients treated with at least one dose of Anetumab will be included. The endpoint is any response using the RECIST 1.1 criteria.

Being tested
anetumab ravtansine
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anetumab ravtansineDrug

    Patients will receive anetumab ravtansine IV infusion at a dose of 6.5 mg/kg (recommended Phase II dose) on Day 1 of a 21-day cycle

Study groups in NCT03023722
Study groupRoleWhat they receive
All SubjectsExperimentalPatients with advanced metastatic pancreatic cancer who have measurable disease
Receives: Drug: anetumab ravtansine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response Rate as Measured Per RECIST 1.1 Criteria

    Primary efficacy will be assessed based on radiological tumor evaluation by contrast-enhanced computed tomography (CT) or contrast-enhanced magnetic resonance imaging (MRI) of chest/abdomen/pelvis. Contrast enhanced RECIST 1.1 scan will be done at Prescreening. Said pre-screen scan will be the baseline measure. RECIST 1.1 Scans will be done every 6 weeks for the first 6 months after the start of treatment, or more frequently if clinically indicated, every 9 weeks until the end of year 2 and every 12 weeks thereafter until disease progression or end of study, whichever comes first.

    Measured: From start of treatment until disease progression or death (up to 3 years).

Secondary outcomes (2)

  1. Time to Progression

    Time to Progression (TTP) defined as time from study treatment to RECIST progression, or death (others going off study will be censored).

    Measured: From start of treatment until disease progression or death (up to 3 years).

  2. Drug Toxicity

    Toxicity of Anetumab ravtansine assessed with National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. See adverse events for details. Participants who experienced any adverse events are included here.

    Measured: From start of treatment until disease progression or death (up to 3 years).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2017 (estimated)
  2. Study start11 May 2017
  3. Primary completion6 Aug 2019
  4. Study completion11 Dec 2019

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03023722
Sponsor's protocol ID
1608018265
Status last verified
Oct 2021
First submitted
13 Jan 2017
Last updated
28 Oct 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anetumab ravtansine in people with Pancreatic Cancer, run by Yale University at 3 sites in United States.

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 33 inclusion and 31 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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in 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 phase mean?

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?

Yes. Results are posted in the registry (first posted 22 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Response Rate as Measured Per RECIST 1.1 Criteria (time frame: From start of treatment until disease progression or death (up to 3 years).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03023722.

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 28 Oct 2021.

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