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AdenocarcinomaPhase 2NCT02943603

A Study of Perioperative mFOLFOX6 Plus Pembrolizumab in Patients With Potentially Resectable Adenocarcinoma of the Gastroesophageal Junction (GEJ) and Stomach

A Phase 2 study testing mFLOFOX6 + pembrolizumab in people with Adenocarcinoma and Stomach Cancer, run by Weijing Sun, MD, FACP at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This research study is being down to find what, effects, good and/or bad, adding Pembrolizumab to standard chemotherapy mFOLFOX before and after surgery have on the patient and the patient's cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Adenocarcinoma, Stomach Cancer
What is being tested?
mFLOFOX6 + pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Jan 2017to Jul 2019
Phase
Phase 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a histologically or cytologically-confirmed diagnosis of adenocarcinoma of the GEJ or stomach.
  • Have newly diagnosed localized or locally advanced (T1N1-3M0 or T2-4NanyM0), potentially resectable disease without any prior systemic chemotherapy.
  • Have no evidence of distant metastases (as determined by EUS, PET-CT or staging laparoscopy).
  • Be eligible and reasonably fit to undergo potentially curative resection
  • Must be 18 - 75 years of age.
  • 6. Be willing and able to provide written informed consent/assent for the trial.
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  • Have measurable disease based on RECIST 1.1.
  • Have pre-resection tissue (EGD or EUS biopsy from the diagnosis) available.
  • Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.
  • Have a performance status of 0 or 1 on the ECOG Performance Scale.
  • Demonstrate adequate organ function:
  • Be willing to provide blood and tissue samples for research purposes
  • Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication.
  • Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.

Who cannot join

  • Has received prior chemotherapy for any malignant disorder, thoracic radiation therapy or prior surgical resection of an esophagogastric tumor.
  • Has biopsy-proven invasion of tracheobronchial tree or tracheo-esophageal fistula.
  • Has distant metastatic disease on imaging or staging laparoscopy at the time of study entry.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  • Has a known history of active TB (Bacillus Tuberculosis)
  • Hypersensitivity to pembrolizumab or any of its excipients.
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  • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  • Clinically significant (≥ grade 2) peripheral neuropathy at the time of study entry.
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Has known history of, or any evidence of active, non-infectious pneumonitis.
  • Has an active infection requiring systemic therapy.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Has known active Hepatitis B or Hepatitis C.
  • Inoperable on the basis of co-existent medical problems.
  • Non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude any of the study drugs.
  • Has received a live vaccine within 30 days of planned start of study therapy.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: A Phase II Study of Perioperative mFOLFOX6 Chemotherapy Plus Pembrolizumab(MK-3475) Combination in Patients With Potentially Resectable Adenocarcinoma of the Gastroesophageal Junction (GEJ) and Stomach

This research study is being down to find what, effects, good and/or bad, adding Pembrolizumab to standard chemotherapy mFOLFOX before and after surgery have on the patient and the patient's cancer.

Being tested
mFLOFOX6 + pembrolizumab
Keywords
mFOLFOX6, pembrolizumab
Medical subject headings
Adenocarcinoma, Stomach Neoplasms

What participants receive

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

  • mFLOFOX6 + pembrolizumabDrug

    the combination of mFOLFOX6 + pembrolizumab is the single intervention even though the is dosed differently.

Study groups in NCT02943603
Study groupRoleWhat they receive
mFOLFX6 + PembrolizumabExperimentalSubjects will receive mFOLFOX6 every 2 weeks (on Days 1, 15, 29, 43) and Pembrolizumab every 3 weeks (on Days 1, 22, 43).
Receives: Drug: mFLOFOX6 + pembrolizumab

What is being measured

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

  1. Rate of pathological complete response [ypCR]

    Number of participants with pathological complete response [pCR] at 12 weeks/total number of evaluable participants.

    Measured: Up to 12 weeks

  2. number of adverse events related to toxicity

    Measured: up to 18 months for accrual + 12 months of intervention and 1 month of safety follow-up for last subject (31 months)

Secondary outcomes (5)

  1. Objective Response Rate (ORR)

    Number of participants with response (partial response + complete response) at 12 weeks/total number of evaluable participants.

    Measured: Up to 12 weeks

  2. Disease Free Survival post surgery

    Measured: up to 18 months for accrual + 1 month for screening and 3 months of intervention before surgery for last subject then 12 months of follow-up (34 months)

  3. Overall Survival (OS)

    Measured: up to 18 months for accrual + 12 months of intervention for last subject (30 months)

  4. PET response

    Measured: up to 18 months for accrual + 1 month for screening and 3 months of intervention for last subject (22 months)

  5. PD-L1 expression in tumor cells

    change in PD-L1 expression on the surface and in the nucleus of the tumor cells over treatment will be related to ypCR by means of logistic regression.

    Measured: up to 18 months for accrual + 1 month for screening and 3 months of intervention for last subject (22 months)

Timeline

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

  1. First posted24 Oct 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionJan 2019 (estimated)
  4. Study completionJul 2019 (estimated)

Why it stopped: No participants enrolled. PI/Sponsor left UPitt. IND withdrawn \& revised protocol submitted through the new institution. New study recruiting under NCT03488667.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02943603
Sponsor's protocol ID
16-104
Status last verified
Sep 2017
First submitted
21 Oct 2016
Last updated
13 Jul 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing mFLOFOX6 + pembrolizumab in people with Adenocarcinoma and Stomach Cancer, run by Weijing Sun, MD, FACP at 1 site 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 15 inclusion and 22 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 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

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?

Rate of pathological complete response [ypCR] (time frame: Up to 12 weeks). The study lists 2 primary outcomes in all. 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 NCT02943603.

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 13 Jul 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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