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AzTrials

Platinum-Resistant Fallopian Tube CarcinomaPhase 1/2NCT03206047

Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

A Phase 1/2 study testing Atezolizumab, DEC-205/NY-ESO-1 Fusion Protein CDX-1401 and Guadecitabine in people with Platinum-Resistant Fallopian Tube Carcinoma and Platinum-Resistant Ovarian Carcinoma, run by National Cancer Institute (NCI) at 17 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This randomized phase I/IIb trial studies side effects and best dose of atezolizumab when given together with guadecitabine and CDX-1401 vaccine and to see how well they work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Atezolizumab, DEC-205/NY-ESO-1 Fusion Protein CDX-1401 and Guadecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
17 sitesUnited States
Study dates
8 Nov 2017to 10 Nov 2020
Phase
Phase 1/2
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma with platinum-resistant disease (defined as having relapsed within 6 months of last platinum-containing regimen because we would like to include both primary and secondary resistance); patients are allowed to have had more than 2 prior cytotoxic treatment regimens; all patients should have received standard of care agents, which confer clinical benefit
  • Presence of biopsiable disease and patient able to undergo pre-treatment and on-treatment biopsy
  • Tissue available from primary and/or recurrent disease to evaluate tumor expression of NY-ESO-1 or PDL1 by immunohistochemistry (IHC) and/or reverse transcriptase-polymerase chain reaction (RT-PCR), and for measurement of DNA methylation
  • No requirement for tumor expression of NY-ESO-1
  • Life expectancy > 6 months as assessed by study physician
  • Because no dosing or adverse event data are currently available on the use of atezolizumab in combination with SGI-110 and CDX-1401 in patients < 18 years of age, children are excluded from this study, but may be eligible for future pediatric trials
Show all 21Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Have been informed of other treatment options
  • Have measurable disease outside of biopsy site present per immune related (ir)RECIST criteria; (Rationale: Biopsy may also induce an inflammatory response and bias outcome measurements)
  • Patients may have received previous NY ESO 1 vaccine therapy; patients who received bevacizumab or other experimental therapies are eligible for enrollment provided they have discontinued therapy (at least 4 weeks) prior to randomization and recovered from toxicities to less than grade 2
  • Leukocytes >= 2,500/mcL
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Hemoglobin >= 10 g/dL
  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x ULN (AST and/or ALT =< 3 x ULN for patients with liver involvement)
  • Alkaline phosphatase =< 2 x ULN (=< 5 x ULN for patients with documented liver involvement or bone metastases)
  • Creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault
  • International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN
  • Administration of the drugs used in this study may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality; women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 5 months (150 days) after the last dose of study agent; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately
  • Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Who cannot join

  • Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation
  • Patients who have had chemotherapy or radiotherapy including complementary and alternative medicine treatments (CAMs) within 4 weeks prior to entering the study or those who have not recovered from adverse events (other than alopecia) due to agents administered more than 4 weeks earlier
  • Prior treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
  • Patients who have received prior treatment with anti-CTLA-4 may be enrolled, provided the following requirements are met:
  • Minimum of 12 weeks from the first dose of anti-CTLA-4 and > 6 weeks from the last dose
  • No history of severe immune-related adverse effects from anti-CTLA-4 (NCI CTCAE grade 3 and 4)
Show all 49Show fewer
  • Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1
  • Treatment with systemic immunostimulatory agents (including, but not limited to, interferon [IFN]-alpha or interleukin [IL]-2) within 6 weeks prior to cycle 1, day 1
  • Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1
  • Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled
  • The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
  • Patients taking bisphosphonate therapy for symptomatic hypercalcemia; use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed
  • Concomitant systemic treatment with chronic use of anti-histamine or non-steroidal anti-inflammatory drugs and other platelet inhibitory agents and patients on oral anticoagulant (e.g. warfarin); exception: patients on therapeutic anticoagulation therapy such as low-molecular-weight heparin or warfarin at a stable dose level are allowed on study
  • Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded
  • Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • History of allergic reactions attributed to compounds of similar chemical or biological composition to other agents used in this study
  • Subjects who have received prior therapy with hypomethylating agents (5-azacytidine, decitabine, SGI-110)
  • Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
  • Lack of ability of a patient for immunological and clinical follow-up assessment
  • Evidence of current drug or alcohol abuse or psychiatric impairment, which in the investigator's opinion will prevent completion of protocol therapy or follow-up
  • Due to unknown effects on the developing fetus or newborn, pregnant or nursing female patients are excluded from this study
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug. (i.e., any significant medical illness or abnormal laboratory finding that would increase the patient's risk by participating in this study)
  • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease
  • Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible
  • Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)
  • History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis
  • Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible
  • Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible
  • Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:
  • Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations
  • Rash must cover less than 10% of body surface area (BSA)
  • Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)
  • No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
  • History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • Patients with active tuberculosis (TB) are excluded
  • Severe infections within 4 weeks prior to cycle 1, day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
  • Received oral or intravenous (IV) antibiotics within 2 weeks prior to cycle 1, day 1; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible
  • Major surgical procedure within 28 days prior to cycle 1, day 1 or anticipation of need for a major surgical procedure during the course of the study
  • Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of atezolizumab
  • Influenza vaccination should be given during influenza season only (approximately October to March); patients must not receive live, attenuated influenza vaccine within 4 weeks prior to cycle 1, day 1 or at any time during the study and until 5 months after the last dose of atezolizumab
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients positive for human immunodeficiency virus (HIV) are NOT excluded from this study, but HIV-positive patients must have:
  • A stable regimen of highly active anti-retroviral therapy (HAART)
  • No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
  • A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests
  • Patients requiring treatment with a RANKL inhibitor (e.g. denosumab) who cannot discontinue it before treatment with atezolizumab

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • University of Kansas Clinical Research Center

    Fairway, Kansas, 66205

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • UC Comprehensive Cancer Center at Silver Cross

    New Lenox, Illinois, 60451

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Nebraska Medicine-Village Pointe

    Omaha, Nebraska, 68118

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • University of Chicago Medicine-Orland Park

    Orland Park, Illinois, 60462

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85719

  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

Other trials in United States

About this study

Official title: A Randomized Phase 2 Trial of Atezolizumab (MPDL3280A), SGI-110 and CDX-1401 Vaccine in Recurrent Ovarian Cancer

This randomized phase I/IIb trial studies side effects and best dose of atezolizumab when given together with guadecitabine and CDX-1401 vaccine and to see how well they work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. CDX-1401 vaccine may enhance the expression of the genes encoding tumor antigens on the surface of tumor cells and enhance the activity of tumor-killing T cells against those tumor cells. Vaccines made from monoclonal antibodies combined with tumor cells may help the body build an effective immune response to kill tumor cells. Giving atezolizumab, guadecitabine, and CDX-1401 vaccine may work better than CDX-1401 alone in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the safety of fixed doses of atezolizumab (MPDL3280A) in combination with guadecitabine (SGI-110). (Phase I) II. To evaluate toxicity of the combination as defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. (Phase I) III. To study if SGI-110 improves the benefit of atezolizumab and then if the further addition of the DEC-205/NY-ESO-1 fusion protein CDX-1401 (CDX-1401)/poly ICLC adds further clinical benefit by analyzing progression free survival (PFS), using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. (Phase IIb)

SECONDARY OBJECTIVES:

  1. To observe and record anti-tumor activity. (Phase I) II. To determine overall survival (OS), objective response rate (complete and partial responses), clinical benefit rate (response + stable disease), CA-125 reduction (percentage of patients with CA-125 reduction by >= 50%), and duration of response. (Phase IIb) III. To assess the impact of the combination of atezolizumab, SGI-110, and CDX-1401 on anti-tumor immune responses. (Phase IIb) IV. To assess the impact of SGI-110 on NY-ESO-1 expression in tumor tissue. (Phase IIb) V. To assess toxicities associated with the combination cohorts (2 and 3), as there is little human experience with these combinations. (Phase IIb)

EXPLORATORY/TRANSLATIONAL OBJECTIVES:

  1. To determine the effectiveness of SGI-110 on enhancing vaccine efficacy by assessing NY ESO 1 specific cellular and humoral immunity.

Ia. Peripheral blood NY ESO 1 specific CD8+ and CD4+ T cells. Ib. Peripheral blood NY ESO 1 specific antibodies. Ic. Peripheral blood unrelated CTA specific antibodies (antigen spreading). Id. Peripheral blood frequency of CD4+CD25+FOXP3+ regulatory T cells. Ie. Examine potential differential effect of NY-ESO-1 expression on PFS. II. To assess the impact on PDL1 expression in tumor tissue. III. Evaluation of therapeutic efficacy on immune cell phenotype. IV. Deoxyribonucleic acid (DNA) methylation and DNA methylome: in pre- and on-treatment peripheral blood, serum (circulating DNA), and tumor biopsies.

  1. Pre-and on-treatment density and location of tumor infiltrating CD3+ and CD8+ T cells.

VI. Evaluate the pre- and post-treatment mutational and neo-antigen load and therapeutic efficacy.

VII. Pre- and post-treatment T cell receptor (TCR) repertoire to study the effect of TCR V beta diversity due to combination of PDL1 blockade, epigenetic modification, and vaccination on therapeutic efficacy.

VIII. Gut microbiota at baseline and one on-treatment sample at C4D1 (cycle 4, day 1) or at progression, whichever is earlier to evaluate the role of microbiota on the therapeutic efficacy of the proposed combination therapy.

OUTLINE: This is a phase I, dose-escalation study of guadecitabine followed by a phase IIb study. Patients are randomized to 1 of 3 cohorts.

COHORT I: Patients receive atezolizumab intravenously (IV) over 30-60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

COHORT II: Patients receive guadecitabine subcutaneously (SC) on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on days 8 and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

COHORT III: Patients receive guadecitabine and atezolizumab as in Cohort II. Patients also receive CDX-1401 vaccine IV on day 15 and poly ICLC SC on days 15-16. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 2 months for up to 1 year.

Being tested
Atezolizumab, DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Guadecitabine, Laboratory Biomarker Analysis, Poly ICLC
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

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

  • AtezolizumabDrug

    Also called MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A

    Given IV

  • DEC-205/NY-ESO-1 Fusion Protein CDX-1401Biological

    Also called CDX-1401

    Given SC

  • GuadecitabineDrug

    Also called DNMT inhibitor SGI-110, S110, SGI 110, SGI-110

    Given SC

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Poly ICLCDrug

    Also called Hiltonol, Poly I:Poly C with Poly-L-Lysine Stabilizer, poly-ICLC, PolyI:PolyC with Poly-L-Lysine Stabilizer

    Given SC

Study groups in NCT03206047
Study groupRoleWhat they receive
Cohort I (atezolizumab)ExperimentalPatients receive atezolizumab IV over 30-60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Atezolizumab; Other: Laboratory Biomarker Analysis
Cohort II (guadecitabine, atezolizumab)ExperimentalPatients receive guadecitabine SC on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on days 8 and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Atezolizumab; Drug: Guadecitabine; Other: Laboratory Biomarker Analysis
Cohort III (guadecitabine, atezolizumab, CDX-1401 vaccine)ExperimentalPatients receive guadecitabine and atezolizumab as in Cohort II. Patients also receive CDX-1401 vaccine IV on day 15 and poly ICLC SC on days 15-16. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Atezolizumab; Biological: DEC-205/NY-ESO-1 Fusion Protein CDX-1401; Drug: Guadecitabine; Other: Laboratory Biomarker Analysis; Drug: Poly ICLC

What is being measured

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

  1. Incidence of Adverse Events (AE) (Phase I)

    The number of patients that had a maximum adverse event >= grade 4 ( Common Terminology Criteria for Adverse Events version 5.0)

    Measured: Up to 30 days after last dose

  2. Progression Free Survival (PFS) (Phase IIb)

    The study was terminated in 2020 early due to the cellular product being discontinued. The study did not proceed to the Phase II, so there were no participants in the Phase II part. The Progression free survival (PFS) (Phase IIb) is not evaluable.

    Measured: Till primary study completion date, approximately 3 years

Secondary outcomes (9)

  1. Anti-tumor Activity (Phase I) II

    The study was terminated in 2020 early due to the cellular product being discontinued. The study did not proceed to the Phase II, so there were no participants in the Phase II part. Anti-tumor activity was not collected.

    Measured: Up to 1 year

  2. Overall Survival (OS) (Phase IIb)

    The study was terminated in 2020 early due to the cellular product being discontinued. The study did not proceed to the Phase II, so there were no participants in the Phase II part. The Overall survival (OS) (Phase IIb) is not evaluable.

    Measured: Till primary study completion date, approximately 3 years

  3. Objective Response Rate (Phase IIb)

    The study was terminated in 2020 early due to the cellular product being discontinued. The study did not proceed to the Phase II, so there were no participants in the Phase II part. TheObjective response rate (Phase IIb) is not evaluable.

    Measured: After 30 days after the last dose of study drug

  4. Clinical Benefit Rate (Phase IIb)

    The study was terminated in 2020 early due to the cellular product being discontinued. The study did not proceed to the Phase II, so there were no participants in the Phase II part. The Clinical benefit rate (Phase IIb) is not evaluable.

    Measured: After 30 days after the last dose of study drug

  5. CA-125 Reduction (Phase IIb)

    The study was terminated in 2020 early due to the cellular product being discontinued. The study did not proceed to the Phase II, so there were no participants in the Phase II part. The CA-125 reduction (Phase IIb) is not evaluable.

    Measured: CA-125 were followed up from the start date of intervention till 39 months.

  6. Duration of Response (Phase IIb)

    The study was terminated in 2020 early due to the cellular product being discontinued. The study did not proceed to the Phase II, so there were no participants in the Phase II part. The Duration of response (Phase IIb) is not evaluable.

    Measured: After 30 days after the last dose of study drug

  7. Anti-tumor Immune Responses

    The study was terminated in 2020 early due to the cellular product being discontinued. The study did not proceed to the Phase II, so there were no participants in the Phase II part. The Anti-tumor immune responses (Phase IIb) is not evaluable.

    Measured: Anti-tumor immune responses were followed up from the start date of intervention till 39 months.

  8. Epigenetic Modification of Immune Gene Signatures, NY-ESO-1, Other CTAs, and PDL 1 in the Tumor Microenvironment

    The study was terminated in 2020 early due to the cellular product being discontinued. The study did not proceed to the Phase II, so there were no participants in the Phase II part. The Epigenetic modification of immune gene signatures, NY-ESO-1, other CTAs, and PDL 1 in the tumor microenvironment (Phase IIb) is not evaluable.

    Measured: Epigenetic modification of immune gene signatures, NY-ESO-1, other CTAs, and PDL 1 in the tumor microenvironment were followed up from the start date of intervention till 39 months.

  9. Incidence of Adverse Events With the Combination Cohorts (2 and 3) (Phase IIb)

    The study was terminated in 2020 early due to the cellular product being discontinued. The study did not proceed to the Phase II, so there were no participants in the Phase II part. The Incidence of adverse events with the combination cohorts (2 and 3) (Phase IIb) is not evaluable.

    Measured: Incidence of adverse events with the combination cohorts (2 and 3) (Phase IIb) were followed up from the start date of intervention till 39 months.

Timeline

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

  1. First posted2 Jul 2017
  2. Study start8 Nov 2017
  3. Primary completion10 Nov 2020
  4. Study completion10 Nov 2020

Why it stopped: The study was terminated due to a shortage of the drug supply.

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03206047
Sponsor's protocol ID
NCI-2017-01030
Other IDs
NCI-2017-01030, I 285416, 10017, 10017, P30CA016056
Status last verified
Sep 2026
First submitted
30 Jun 2017
Last updated
20 Oct 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Atezolizumab, DEC-205/NY-ESO-1 Fusion Protein CDX-1401 and Guadecitabine in people with Platinum-Resistant Fallopian Tube Carcinoma and Platinum-Resistant Ovarian Carcinoma, run by National Cancer Institute (NCI) at 17 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 21 inclusion and 49 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: stopped early, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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 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?

Yes. Results are posted in the registry (first posted 20 Oct 2026). 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?

Incidence of Adverse Events (AE) (Phase I) (time frame: Up to 30 days after last dose). 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 NCT03206047.

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 20 Oct 2026.

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