AzTrials
AzTrials

Esophageal CancerPhase 2RHAPSODYNCT04494009

PD-1 Inhibitor INCMGA00012 as Consolidation Therapy After Definitive Concurrent Chemoradiotherapy

A Phase 2 study testing INCMGA00012 in people with Esophageal Cancer, run by Asan Medical Center at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study is a randomized, multi-center, open-label, phase II study of a PD-1 inhibitor (INCMGA00012) versus observation as consolidation therapy after definitive concurrent chemoradiotherapy in patients with locally advanced ESCC who have not progressed following definitive chemoradiotherapy. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Esophageal Cancer
What is being tested?
INCMGA00012
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteSouth Korea
Study dates
7 Sep 2020to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be willing and able to provide written informed consent for the trial.
  • Be ≥19 years of age on the day of signing the informed consent.
  • Have ECOG performance status 0-2 (Appendix 1).
  • Have histologically proven esophageal squamous cell carcinoma (ESCC).
  • Have demonstrated cT1b N1-3 M0 or T2-4b N0-3 M0 (8th AJCC staging system) before definitive chemoradiotherapy (Appendix 2).
  • Have completed definitive concurrent chemoradiotherapy for esophageal cancer due to unresectable disease status (such as cervical esophageal cancer and T4b), medically inoperable status, or patient's refusal of undergoing surgery.
Show all 17Show fewer
  • Have received fluoropyrimidine or taxane plus platinum chemotherapy (including, but not limited to fluorouracil plus cisplatin, capecitabine plus cisplatin, and paclitaxel plus carboplatin according to the institute standard of care regimens) concurrent with radiation therapy. One or two cycles of induction chemotherapy before chemoradiotherapy is allowed, but chemotherapy after concurrent chemoradiotherapy is not allowed.
  • Have received a total dose of radiation of at least 50 Gy as part of concurrent chemoradiotherapy.
  • Have not progressed following definitive chemoradiotherapy assessed by 18F-FDG-PET (or PET-CT) scan, esophagogastroduodenoscopy (EGD), and chest CT. Clinical response should be evaluated within 4 to 8 weeks after completing definitive chemoradiotherapy, and within 3 weeks before randomization.
  • Have available pre-treatment tumor tissue for biomarker analyses. Either 1 formalin-fixed paraffin embedded (FFPE) tumor tissue block or 20 unstained tumor tissue slides must be submitted for biomarker evaluation. Post-chemoradiation biopsy should be performed if it is technically feasible and is not associated with unacceptable clinical risk, and in case of pathologic residual cancer, tumor tissue for biomarker analyses should be submitted (Either 1 FFPE tumor tissue block or 20 unstained tumor tissue slides).
  • Have adequate major organ functions as demonstrated by following laboratory results obtained within 14 days prior to randomization (these lab criteria should be also met within 7 days before initiation of study drug):
  • Adequate bone marrow function as defined by absolute neutrophil count (ANC) ≥ 1,000/mm3 and platelet count ≥ 75,000/mm3 without receiving growth factors or blood transfusion within 7 days before the laboratory testing.
  • Adequate renal function with serum creatinine ≤ 1.5 x upper limit of normal (ULN) or creatinine clearance ≥50 mL/minute by calculation using the Cockcroft-Gault formula (Appendix 3) or measurement using a preferred method per institute standard of care.
  • Adequate hepatic function with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN, and serum total bilirubin ≤ 1.5 x ULN except for subjects with Gilbert syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology) who may be enrolled despite a total bilirubin level > 1.5 x ULN.
  • Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 14 days prior to randomization. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Female subjects of childbearing potential randomized to the INCMGA00012 arm must be willing to use an adequate method of contraception for the duration of study treatment and 90 days after the last dose of study treatment.
  • Non-sterile male subjects randomized to the INCMGA00012 arm and who have female sexual partner(s) of childbearing potential must agree to use an adequate method of contraception for the duration of study treatment and 90 days after the last dose of study treatment.

Who cannot join

  • Has demonstrated disease progression while or after completion of definitive chemoradiotherapy for locally advanced ESCC.
  • Has received sequential chemotherapy or chemoradiotherapy after completion of concurrent chemoradiotherapy for locally advanced ESCC.
  • Has received any immunotherapy or investigational drug within 4 weeks prior to randomization.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  • Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy, investigational agent, or local treatment (except for stent insertion or feeding enterostomy for palliative intent) for cancer treatment.
  • Any unresolved toxicities CTCAE grade ≥2 from prior therapy with the exception of alopecia, fatigue, and neuropathy.
Show all 23Show fewer
  • Has undergone major surgery within 4 weeks prior to entry into the study.
  • Has an active autoimmune disease that has required systemic treatment within the 2 years prior to entry into the study (i.e., with use of disease-modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal insufficiency of pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
  • Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (>10 mg/day prednisolone or equivalents) or any other form of immunosuppressive therapy within 14 days prior to entry into the study. Note: A use of topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption) is allowed. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
  • Has a history of organ transplant, including stem cell allograft.
  • Has received a live vaccine within 30 days prior to entry into the study. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
  • Has an active infection requiring systemic therapy.
  • Has known history of Human Immunodeficiency Virus (HIV) infection.
  • Has active HBV (detectable HBsAg or HBV DNA) or HCV infection (detectable HCV RNA):
  • o For the subject receiving antiviral agents for HBV at screening, if the subject has been treated for > 2 weeks and HBV DNA is <500 IU/mL (or 2,500 copies/mL) prior to randomization, the subject will be allowed to be enrolled in the study. Antiviral agent should be continued for 6 months after study drug treatment discontinuation.
  • Has known history of, or any evidence of interstitial lung disease, non-infectious pneumonitis, or pulmonary fibrosis diagnosed based on imaging or clinical findings. Note: Subjects with radiation pneumonitis may be enrolled if the radiation pneumonitis has been confirmed as stable (beyond acute phase) and is unlikely to recur.
  • Has history of another primary malignancy requiring active treatment within the previous 3 years except for adequately treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ (e.g., of cervix, breast, prostate).
  • Has medical or psychiatric conditions that compromise the subject's ability to give informed consent or to complete the protocol or a history of non-compliance.
  • Has significant cardiovascular impairment within 6 months prior to entry to the study such as history of congestive heart failure meeting New York Heart Association (NYHA) Class III or IV, unstable angina, myocardial infarction, cerebrovascular accident, or cardiac arrhythmia associated with hemodynamic instability.
  • Has a history of severe hypersensitivity to antibody products.
  • 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.
  • Is a pregnant or breastfeeding woman.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

About this study

Official title: Randomized Phase II Trial of a PD-1 Inhibitor INCMGA00012 as Consolidation Therapy After Definitive Concurrent Chemoradiotherapy for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma (RHAPSODY)

This study is a randomized, multi-center, open-label, phase II study of a PD-1 inhibitor (INCMGA00012) versus observation as consolidation therapy after definitive concurrent chemoradiotherapy in patients with locally advanced ESCC who have not progressed following definitive chemoradiotherapy.

Read the detailed description

This study is a randomized, multi-center, open-label, phase II study of a PD-1 inhibitor (INCMGA00012) versus observation as consolidation therapy after definitive concurrent chemoradiotherapy in patients with locally advanced ESCC who have not progressed following definitive chemoradiotherapy.

Patients must have received definitive concurrent chemoradiotherapy for locally advanced ESCC (cT1b N1-3 M0 or T2-4b N0-3 M0 according to the 8th American Joint Committee on Cancer [AJCC] staging system) because of unresectable disease status (such as cervical esophageal cancer and cTb), medically inoperable status, or patient's refusal of undergoing surgery.

Patients must not have progressed following definitive chemoradiotherapy consisting of fluoropyrimidine or taxane plus platinum chemotherapy (including, but not limited to fluorouracil plus cisplatin, capecitabine plus cisplatin, and paclitaxel plus carboplatin according to the institute standard of care regimens) concurrent with radiation therapy (a total dose of at least 50 Gy). One or two cycles of induction chemotherapy before chemoradiotherapy is allowed, but chemotherapy after concurrent chemoradiotherapy is not allowed.

Approximately 110 patients who have not progressed following definitive chemoradiotherapy for locally advanced ESCC will be randomly assigned within 4-8 weeks after completing chemoradiotherapy in a 1:1 ratio to the INCMGA00012 arm or observation arm.

  • INCMGA00012 arm (500 mg iv every 4 weeks for up to 12 months)
  • Observation arm (followed-up every 3 months) Randomization will be stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0-1 vs. 2), clinical response to definitive chemoradiation (complete response [CR] vs. non-CR), and institute.
Being tested
INCMGA00012
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • INCMGA00012Drug

    INCMGA00012 (also known as MGA012) is a humanized, hinge-stabilized IgG4 monoclonal antibody against human PD-1, which blocks the interaction of PD-1 with PD-L1 and PD-L2, interrupting PD-1 signaling, enhances antigen-induced interferon-γ release, and has a favorable preclinical profile.

Study groups in NCT04494009
Study groupRoleWhat they receive
INCMGA00012 군ExperimentalINCMGA00012 500 mg iv every 4 weeks for up to 12 months
Receives: Drug: INCMGA00012
Observation armNo interventionfollowed up every 12 weeks for up to 12 months

What is being measured

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

  1. Progression Free Survival per RECIST 1.1

    Every 12 weeks during the first two years after randomization then every 24 weeks

    Measured: 5 Years

Secondary outcomes (7)

  1. Overall Survival

    every visit

    Measured: 5 Years

  2. Progression Free Survival per iRECIST

    Every 12 weeks during the first two years after randomization then every 24 weeks

    Measured: 5 Years

  3. Time To Progression per RECIST 1.1

    Every 12 weeks during the first two years after randomization then every 24 weeks

    Measured: 5 Years

  4. Time To Progression per iRECIST Time To Progression per iRECIST

    Every 12 weeks during the first two years after randomization then every 24 weeks

    Measured: 5 Years

  5. To compare pattern of first cause of progression

    Every 12 weeks during the first two years after randomization then every 24 weeks

    Measured: 5 Years

  6. To compare the safety and tolerability(NCI-CTCAE version 5.0)

    every visit

    Measured: 5 Years

  7. HRQoL, time to deterioration

    Every 12 weeks during the first two years after randomization then every 24 weeks

    Measured: 5 Years

Timeline

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

  1. First posted31 Jul 2020
  2. Study start7 Sep 2020
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04494009
Sponsor's protocol ID
MC20-01
Acronym
RHAPSODY
Status last verified
May 2026
First submitted
14 Jul 2020
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chitti B, Pham A, Marcott S, Wang X, Potters L, Wernicke AG, Parashar B. Temporal Changes in Esophageal Cancer Mortality by Geographic Region: A Population-based Analysis. Cureus. 2018 Nov 15;10(11):e3596. doi: 10.7759/cureus.3596.

    PubMed 30680257

  • Murphy G, McCormack V, Abedi-Ardekani B, Arnold M, Camargo MC, Dar NA, Dawsey SM, Etemadi A, Fitzgerald RC, Fleischer DE, Freedman ND, Goldstein AM, Gopal S, Hashemian M, Hu N, Hyland PL, Kaimila B, Kamangar F, Malekzadeh R, Mathew CG, Menya D, Mulima G, Mwachiro MM, Mwasamwaja A, Pritchett N, Qiao YL, Ribeiro-Pinto LF, Ricciardone M, Schuz J, Sitas F, Taylor PR, Van Loon K, Wang SM, Wei WQ, Wild CP, Wu C, Abnet CC, Chanock SJ, Brennan P. International cancer seminars: a focus on esophageal squamous cell carcinoma. Ann Oncol. 2017 Sep 1;28(9):2086-2093. doi: 10.1093/annonc/mdx279.

    PubMed 28911061

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing INCMGA00012 in people with Esophageal Cancer, run by Asan Medical Center at 1 site in South Korea.

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 17 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. 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 South Korea. 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?

This study is still under way. Results are not available in the source record yet.

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?

Progression Free Survival per RECIST 1.1 (time frame: 5 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 NCT04494009, which also lists 2 linked publications.

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 22 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in