Cervical CarcinomaPhase 2NCT03220009
Nivolumab or Expectant Observation Following Ipilimumab, Nivolumab, and Surgery in Treating Patients With High Risk Localized, Locoregionally Advanced, or Recurrent Mucosal Melanoma
A Phase 2 study testing Conventional Surgery, Ipilimumab and Laboratory Biomarker Analysis in people with Cervical Carcinoma and Esophageal Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This randomized phase II trial studies how well nivolumab or expectant observation following ipilimumab, nivolumab, and surgery work in treating patients with high-risk mucosal melanoma that is restricted to the site of origin without evidence of spread, has spread to a local and regional area of the body, or has come… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Carcinoma, Esophageal Carcinoma, Mucosal Melanoma
- What is being tested?
- Conventional Surgery, Ipilimumab and Laboratory Biomarker Analysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2017to 1 Jul 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- STEP 1 ELIGIBILITY CRITERIA
- Documentation of disease:
- Histologic documentation: histologically proven mucosal melanoma by local pathology
- Tumor tissue: tumor tissue from the primary site of disease must be available for PD-L1 testing (stratification factor)
- Disease status
- Tumors must have NOT been completely resected, or must be locoregionally recurrent if previously resected; tumor must be deemed potentially resectable by local surgeon
Show all 66Show fewer
- MM arising from the head/neck, genitourinary, or gastrointestinal tract
- Disease meets any 1 of 4 characteristics:
- Regional lymph node (LN) involvement; OR
- Multifocal/satellite primary disease; OR
- Single localized, primary disease meeting one of the following site-specific requirements:
- Head/neck - any primary lesion if sinonasal; pT4a or above for nasal or oral cavity
- Anorectal - any primary lesion
- Conjunctiva - any primary lesion T2 or T3 stage by American Joint Committee on Cancer (AJCC)
- Vaginal/cervical - any primary
- Vulvar (hair bearing surface, labia majora) - AJCC cutaneous stage IIB or higher
- Esophageal - any primary
- Locoregionally recurrent following prior resection
- No evidence of metastatic disease at the time of registration
- No prior medical therapy (chemotherapy, immunotherapy, biologic or targeted therapy) or radiation therapy for MM, unless locoregionally recurrent; if recurrent, no prior medical or radiation therapy is allowed for the latest recurrence
- No history of the following:
- Active known or suspected autoimmune disease
- Human immunodeficiency virus (HIV) with CD4+ count < 300 or detectable viral load; patients with HIV, undetectable viral load, and CD4+ count >= 300 are eligible
- Known active hepatitis B or C
- Hepatitis B can be defined as:
- Hepatitis B virus surface antigen (HBsAg) > 6 months
- Serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) 20,000 IU/ml (105 copies/ml), lower values 2,000-20,000 IU/ml (104-105 copies/ml) are often seen in hepatitis B virus e antigen (HBeAg)-negative chronic hepatitis B
- Persistent or intermittent elevation in alanine aminotransferase (ALT)/aspartate aminotransferase (AST) levels
- Liver biopsy showing chronic hepatitis with moderate or severe necroinflammation
- Hepatitis C can be defined as:
- Hepatitis C antibody (AB) positive
- Presence of hepatitis C virus (HCV) RNA
- Known active pulmonary disease with hypoxia defined as oxygen saturation < 85% on room air
- Not pregnant and not nursing
- For women of childbearing potential only, a negative pregnancy test done =< 14 days prior to registration is required
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Absolute neutrophil count (ANC) >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Creatinine clearance >= 30 mL/min by Modified Diet in Renal Disease (MDRD) equation or Cockcroft-Gault
- Total bilirubin =< 1.5 x upper limit of normal (ULN)
- Except in case of Gilbert disease
- AST/ALT =< 2.5 x upper limit of normal (ULN)
- Thyroid-stimulating hormone (TSH) within normal limits (WNL)
- Supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH if free T4 is normal and patient is clinically euthyroid, patient is eligible
- Concomitant medications
- No systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days of registration (inhaled steroids for patients with underlying chronic pulmonary disease is acceptable as long as they meet other eligibility as listed above)
- No other planned concurrent investigational agents or other tumor directed therapy (chemotherapy, radiation) while on study
- STEP 2 ELIGIBILITY CRITERIA
- Surgical resection of all gross disease
- This assessment will be made by the local investigator based on review of the operative report, pathology results, and/or radiology reports; microscopically positive margins (e.g. R1 resection) are permitted
- Completion of PD-L1 testing
- Patients will be stratified as PD-L1 >= 5% versus (vs) < 5% OR inevaluable; baseline tumor will be utilized; if this returns inevaluable, efforts should be made to utilize the resected specimen
- Randomization within 112 days of completion of surgical
- The primary region must be included on cross-sectional imaging (e.g. sinus/neck if arising from sinonasal primary; pelvis if genitourinary); radiographic changes considered nonspecific or possibly due to surgery or radiation are not considered evidence of disease
- No significant immune-related adverse event due to the nivolumab plus ipilimumab dose received in the neoadjuvant setting, as follows:
- Any grade myocarditis, including an asymptomatic troponin elevation felt to be related to nivolumab plus ipilimumab
- Any grade neurologic complication (e.g. meningitis, encephalitis, neuropathy); study chair should be contacted if there is any question whether an adverse event (AE) was neurologic in nature
- Grade 2 or higher pneumonitis
- Grade 2 colitis
- Grade 2 or higher anemia (due to drug; unrelated anemia is not exclusionary)
- Thyroid/adrenal AEs regardless of grade that have stabilized or are clinically asymptomatic are eligible
- Fatigue, regardless of grade, is not a contraindication to randomization
- Grade 4 AST or ALT elevation
- Asymptomatic elevated amylase and lipase, regardless of grade, are not contraindications to randomization
- Grade 4 rash; grade 3 rash is not a contraindication to randomization; any oropharyngeal lesions or bullous skin lesions that are suggestive of toxic epidermal necrolysis or Stevens-Johnson syndrome are contraindications to randomization regardless of the grade of rash
- If not specified above, other Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher AEs deemed possibly related to the nivolumab plus ipilimumab are exclusions to randomization; AEs that were attributable to surgery or adjuvant RT would not be contraindications to randomization
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Alliance for Clinical Trials in Oncology
Boston, Massachusetts, 02115
About this study
Official title: A Randomized Phase II Trial of Adjuvant Nivolumab or Expectant Observation Following Neoadjuvant Ipilimumab Plus Nivolumab and Surgical Resection of High-Risk Localized, Locoregionally Advanced, or Recurrent Mucosal Melanoma
This randomized phase II trial studies how well nivolumab or expectant observation following ipilimumab, nivolumab, and surgery work in treating patients with high-risk mucosal melanoma that is restricted to the site of origin without evidence of spread, has spread to a local and regional area of the body, or has come back. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Sometimes the mucosal melanoma may not need more treatment until it progresses. In this case, observation may be sufficient. It is not known if nivolumab or expectant observation following ipilimumab, nivolumab, and surgery may be better in treating patients with mucosal melanoma.
Read the detailed description
PRIMARY OBJECTIVES:
- Recurrence free survival (RFS) in patients with mucosal melanoma (MM) treated with neoadjuvant ipilimumab plus nivolumab and surgery followed by adjuvant nivolumab and expectant observation.
SECONDARY OBJECTIVES:
- Pathologic complete response with neoadjuvant ipilimumab plus nivolumab. II. Distant recurrence-free survival (DRFS) with adjuvant nivolumab and expectant observation.
III. Overall survival (OS) with adjuvant nivolumab and expectant observation. IV. Safety/toxicity as measured by maximum grade adverse event in (a) the neoadjuvant setting, (b) the adjuvant nivolumab cohort after randomization, and (c) the observation cohort after randomization.
- Rate of delayed primary surgery.
TERTIARY OBJECTIVES:
- Demonstrate that baseline tumors harboring a higher neoepitope burden have superior median RFS than those who have a lower neoepitope burden in the arm receiving adjuvant nivolumab.
II. Demonstrate that tumors with higher CD8+ infiltration at the tumor invasive margin at surgical resection have superior median RFS than those with lower CD8+ infiltration.
III. Demonstrate that tumors harboring a "T cell inflamed" ribonucleic acid (RNA) expression signature at surgical resection following neoadjuvant nivolumab plus ipilimumab have a superior distant RFS than those harboring a "non-T cell inflamed" signature, both in the overall group and within those who receive adjuvant nivolumab.
IV. Identify recurrent genetic alterations at baseline that are associated with higher CD8+/PD1+ infiltration at baseline and following 1 dose of neoadjuvant nivolumab plus ipilimumab.
- Tumor response rate will be estimated based on patients whose imaging are captured and submitted during the neo-adjuvant portion of the study (imaging is not required).
OUTLINE:
PART I: Patients receive nivolumab intravenously (IV) over 30 minutes and ipilimumab IV over 30 minutes on day 1. Within 3-6 weeks after receiving nivolumab and ipilimumab, patients undergo surgery per standard of care. Within 84 days of last surgical resection, patients may also undergo adjuvant radiation therapy (RT), if clinically appropriate.
PART II: Within 84 days of last surgical resection, patients are randomized to 1 of 2 arms.
ARM I: Patients undergo active surveillance for 1 year.
ARM II: Patients receive nivolumab IV over 30 minutes once every 2 weeks for 4 doses. Patients then continue to receive nivolumab IV over 30 minutes once every 4 weeks for up to 11 doses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 90 days for 2 years, every 180 days for 3 years or until disease progression, whichever is first, and every 6 months thereafter until a maximum of 5 years following registration.
- Conditions
- Cervical Carcinoma, Esophageal Carcinoma, Mucosal Melanoma, Mucosal Melanoma of the Head and Neck, Oral Cavity Mucosal Melanoma, Recurrent Melanoma
- Being tested
- Conventional Surgery, Ipilimumab, Laboratory Biomarker Analysis, Nivolumab, Patient Observation
- Medical subject headings
- Uterine Cervical Neoplasms, Esophageal Neoplasms, Melanoma, Vulvar Neoplasms, Vaginal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional SurgeryProcedure or surgery
Undergo surgery
IpilimumabBiological
Also called Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, MDX-010, MDX-CTLA4
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
NivolumabBiological
Also called BMS-936558, MDX-1106, NIVO, ONO-4538
Given IV
Patient ObservationOther
Also called Active Surveillance, deferred therapy, expectant management, observation
Undergo active surveillance
Radiation TherapyRadiation
Also called Cancer Radiotherapy, Irradiate, Irradiated, irradiation
Undergo RT
| Study group | Role | What they receive |
|---|---|---|
| Arm I (nivolumab, ipilimumab, surgery, active surveillance) | Active comparator | PART I: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1. Within 3-6 weeks after receiving nivolumab and ipilimumab, patients undergo surgery per standard of care. Within 84 days of last surgical resection, patients may also undergo adjuvant RT, if clinically appropriate.
PART II: Patients undergo active surveillance for 1 year. Receives: Procedure: Conventional Surgery; Biological: Ipilimumab; Other: Laboratory Biomarker Analysis; Biological: Nivolumab; Other: Patient Observation; Radiation: Radiation Therapy |
| Arm II (nivolumab, ipilimumab, surgery, nivolumab) | Experimental | PART I: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1. Within 3-6 weeks after receiving nivolumab and ipilimumab, patients undergo surgery per standard of care. Within 84 days of last surgical resection, patients may also undergo adjuvant RT, if clinically appropriate.
PART II: Patients receive nivolumab IV over 30 minutes once every 2 weeks for 4 doses. Patients then continue to receive nivolumab IV over 30 minutes once every 4 weeks for up to 11 doses in the absence of disease progression or unacceptable toxicity. Receives: Procedure: Conventional Surgery; Biological: Ipilimumab; Other: Laboratory Biomarker Analysis; Biological: Nivolumab; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free survival (RFS)
RFS of patients receiving adjuvant nivolumab will be compared to patients undergoing observation. Kaplan- Meier curves will be constructed and median RFS times will be calculated for each arm.
Measured: From randomization to either adjuvant nivolumab or observation until evidence of disease recurrence, assessed up to 5 years
Secondary outcomes (4)
Distant recurrence-free survival (DRFS)
Will be evaluated using the Kaplan- Meier method. Median times to DRFS will be calculated for each arm and a cox proportional hazards model will be constructed to determine if there is a DRFS benefit for patients in the adjuvant Nivolumab arm (compared to observation).
Measured: From randomization to either adjuvant nivolumab or observation until a distant recurrence is observed, assessed up to 5 years
Incidence of adverse events evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Maximum grade adverse events will be summarized in each of the following settings: during the neo-adjuvant phase of the trial (i.e. from registration until a patient is randomized to adjuvant nivolumab or observation), the adjuvant nivolumab arm after randomization, he observation arm after randomization.
Measured: Up to 5 years
Overall survival (OS)
Will be evaluated using the Kaplan- Meier method. Median OS times will be calculated for each arm and a cox proportional hazards model will be constructed to determine if there is a DRFS benefit for patients in the adjuvant Nivolumab arm (compared to observation).
Measured: From randomization to either adjuvant nivolumab or observation until death due to any cause; assessed up to 5 years
Rate of delayed surgery
Reasons for delay will be summarized and the rate of delay will be calculated along with a 95% confidence interval using the properties of the binomial distribution.
Measured: Up to 6 weeks after registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start3 Nov 2017
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Why it stopped: The study was never approved by CTEP neither was it ever activated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Alexander Shoushtari, Principal investigator, Alliance for Clinical Trials in Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220009
- Sponsor's protocol ID
- NCI-2017-01239
- Other IDs
- NCI-2017-01239, A091603, A091603, U10CA180821
- Status last verified
- Oct 2018
- First submitted
- 17 Jul 2017
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Adjuvant Nivolumab or Expectant Observation Following Neoadjuvant Ipilimumab Plus Nivolumab and Surgical Resection of High-Risk Localized, Locoregionally Advanced, or Recurrent Mucosal Melanoma
- ClinicalTrials.gov ID
- NCT03220009
- Acronym / sponsor ID
- NCI-2017-01239
- Conditions
- Cervical Carcinoma, Esophageal Carcinoma, Mucosal Melanoma, Mucosal Melanoma of the Head and Neck, Oral Cavity Mucosal Melanoma, Recurrent Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was never approved by CTEP neither was it ever activated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 18 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase II trial studies how well nivolumab or expectant observation following ipilimumab, nivolumab, and surgery work in treating patients with high-risk mucosal melanoma that is restricted to the site of origin without evidence of spread, has spread to a local and regional area of the body, or has come back. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Sometimes the mucosal melanoma may not need more treatment until it progresses. In this case, observation may be sufficient. It is not known if nivolumab or expectant observation following ipilimumab, nivolumab, and surgery may be better in treating patients with mucosal melanoma.
Detailed description
PRIMARY OBJECTIVES:
- Recurrence free survival (RFS) in patients with mucosal melanoma (MM) treated with neoadjuvant ipilimumab plus nivolumab and surgery followed by adjuvant nivolumab and expectant observation.
SECONDARY OBJECTIVES:
- Pathologic complete response with neoadjuvant ipilimumab plus nivolumab. II. Distant recurrence-free survival (DRFS) with adjuvant nivolumab and expectant observation.
III. Overall survival (OS) with adjuvant nivolumab and expectant observation. IV. Safety/toxicity as measured by maximum grade adverse event in (a) the neoadjuvant setting, (b) the adjuvant nivolumab cohort after randomization, and (c) the observation cohort after randomization.
- Rate of delayed primary surgery.
TERTIARY OBJECTIVES:
- Demonstrate that baseline tumors harboring a higher neoepitope burden have superior median RFS than those who have a lower neoepitope burden in the arm receiving adjuvant nivolumab.
II. Demonstrate that tumors with higher CD8+ infiltration at the tumor invasive margin at surgical resection have superior median RFS than those with lower CD8+ infiltration.
III. Demonstrate that tumors harboring a "T cell inflamed" ribonucleic acid (RNA) expression signature at surgical resection following neoadjuvant nivolumab plus ipilimumab have a superior distant RFS than those harboring a "non-T cell inflamed" signature, both in the overall group and within those who receive adjuvant nivolumab.
IV. Identify recurrent genetic alterations at baseline that are associated with higher CD8+/PD1+ infiltration at baseline and following 1 dose of neoadjuvant nivolumab plus ipilimumab.
- Tumor response rate will be estimated based on patients whose imaging are captured and submitted during the neo-adjuvant portion of the study (imaging is not required).
OUTLINE:
PART I: Patients receive nivolumab intravenously (IV) over 30 minutes and ipilimumab IV over 30 minutes on day 1. Within 3-6 weeks after receiving nivolumab and ipilimumab, patients undergo surgery per standard of care. Within 84 days of last surgical resection, patients may also undergo adjuvant radiation therapy (RT), if clinically appropriate.
PART II: Within 84 days of last surgical resection, patients are randomized to 1 of 2 arms.
ARM I: Patients undergo active surveillance for 1 year.
ARM II: Patients receive nivolumab IV over 30 minutes once every 2 weeks for 4 doses. Patients then continue to receive nivolumab IV over 30 minutes once every 4 weeks for up to 11 doses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 90 days for 2 years, every 180 days for 3 years or until disease progression, whichever is first, and every 6 months thereafter until a maximum of 5 years following registration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (nivolumab, ipilimumab, surgery, active surveillance) | Active comparator | Procedure: Conventional Surgery, Biological: Ipilimumab, Other: Laboratory Biomarker Analysis, Biological: Nivolumab, Other: Patient Observation, Radiation: Radiation TherapyPART I: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1. Within 3-6 weeks after receiving nivolumab and ipilimumab, patients undergo surgery per standard of care. Within 84 days of last surgical resection, patients may also undergo adjuvant RT, if clinically appropriate. PART II: Patients undergo active surveillance for 1 year. |
| Arm II (nivolumab, ipilimumab, surgery, nivolumab) | Experimental | Procedure: Conventional Surgery, Biological: Ipilimumab, Other: Laboratory Biomarker Analysis, Biological: Nivolumab, Radiation: Radiation TherapyPART I: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1. Within 3-6 weeks after receiving nivolumab and ipilimumab, patients undergo surgery per standard of care. Within 84 days of last surgical resection, patients may also undergo adjuvant RT, if clinically appropriate. PART II: Patients receive nivolumab IV over 30 minutes once every 2 weeks for 4 doses. Patients then continue to receive nivolumab IV over 30 minutes once every 4 weeks for up to 11 doses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (66 listed)
- STEP 1 ELIGIBILITY CRITERIA
- Documentation of disease:
- Disease status
- No prior medical therapy (chemotherapy, immunotherapy, biologic or targeted therapy) or radiation therapy for MM, unless locoregionally recurrent; if recurrent, no prior medical or radiation therapy is allowed for the latest recurrence
- No history of the following:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional SurgeryUndergo surgery | Procedure or surgery | Arm I (nivolumab, ipilimumab, surgery, active surveillance), Arm II (nivolumab, ipilimumab, surgery, nivolumab) |
| IpilimumabAlso: Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, MDX-010, MDX-CTLA4Given IV | Biological | Arm I (nivolumab, ipilimumab, surgery, active surveillance), Arm II (nivolumab, ipilimumab, surgery, nivolumab) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (nivolumab, ipilimumab, surgery, active surveillance), Arm II (nivolumab, ipilimumab, surgery, nivolumab) |
| NivolumabAlso: BMS-936558, MDX-1106, NIVO, ONO-4538Given IV | Biological | Arm I (nivolumab, ipilimumab, surgery, active surveillance), Arm II (nivolumab, ipilimumab, surgery, nivolumab) |
| Patient ObservationAlso: Active Surveillance, deferred therapy, expectant management, observationUndergo active surveillance | Other | Arm I (nivolumab, ipilimumab, surgery, active surveillance) |
| Radiation TherapyAlso: Cancer Radiotherapy, Irradiate, Irradiated, irradiationUndergo RT | Radiation | Arm I (nivolumab, ipilimumab, surgery, active surveillance), Arm II (nivolumab, ipilimumab, surgery, nivolumab) |
Primary outcome
Recurrence free survival (RFS)
Time frame: From randomization to either adjuvant nivolumab or observation until evidence of disease recurrence, assessed up to 5 years
RFS of patients receiving adjuvant nivolumab will be compared to patients undergoing observation. Kaplan- Meier curves will be constructed and median RFS times will be calculated for each arm.
4 secondary outcomes
Distant recurrence-free survival (DRFS)
Time frame: From randomization to either adjuvant nivolumab or observation until a distant recurrence is observed, assessed up to 5 years
Incidence of adverse events evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time frame: Up to 5 years
Overall survival (OS)
Time frame: From randomization to either adjuvant nivolumab or observation until death due to any cause; assessed up to 5 years
Rate of delayed surgery
Time frame: Up to 6 weeks after registration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Shoushtari principal investigator
Alliance for Clinical Trials in Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Conventional Surgery, Ipilimumab and Laboratory Biomarker Analysis in people with Cervical Carcinoma and Esophageal Carcinoma, run by National Cancer Institute (NCI) 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 66 inclusion and 0 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 3 Oct 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?
Recurrence free survival (RFS) (time frame: From randomization to either adjuvant nivolumab or observation until evidence of disease recurrence, assessed up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2018.