Pancreatic Adenocarcinoma, Resectable Pancreatic Carcinoma
Conditions
Brief summary
This phase II trial studies how well nab-paclitaxel and gemcitabine hydrochloride followed by radiation therapy before surgery work in treating patients with pancreatic cancer that can be removed by surgery. Chemotherapy drugs, such as nab-paclitaxel and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving nab-paclitaxel, gemcitabine hydrochloride, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Detailed description
PRIMARY OBJECTIVE: I. To determine the R0 (complete resection) resection rate for subjects with borderline resectable or lymph node positive pancreatic adenocarcinoma treated with a multimodality neoadjuvant therapy of preoperative gemcitabine (gemcitabine hydrochloride) and ABRAXANE (nab-paclitaxel) followed by 5-fluorouracil (fluorouracil) based image-guided intensity-modulated radiation therapy (IG-IMRT) chemoradiotherapy. SECONDARY OBJECTIVES: I. To determine 1-year relapse-free survival rate with the investigational protocol. II. To determine 1-year and 2-year overall survival rates. III. To assess response rate by imaging (Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) and pathologic analysis. IV. To assess the toxicity and safety according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) criteria. OUTLINE: PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel intravenously (IV) over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks. SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation. POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 12 weeks for 1 year.
Interventions
DRUGGemcitabine
Given IV
RADIATIONImage Guided Radiation Therapy
Undergo IG-IMRT
RADIATIONIntensity-Modulated Radiation Therapy
Undergo IG-IMRT
OTHERLaboratory Biomarker Analysis
Correlative studies
DRUGNab-paclitaxel
Given IV
PROCEDURETherapeutic Conventional Surgery
Undergo surgery
DRUGFluorouracil
Given IV
Sponsors
Oregon Health and Science University
Celgene Corporation
OHSU Knight Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have histologically or cytologically confirmed adenocarcinoma of the pancreas * Tumors must be localized (non-metastatic) and classified as borderline resectable according to Americas Hepato-Pancreato-Biliary Association (AHPBA)/Society of Surgical Oncology (SSO)/Society for Surgery of the Alimentary Tract (SSAT) consensus criteria or be clinically node-positive via computed tomography (CT) or endoscopic ultrasound * AHPBA/SSO/SSAT criteria (any one of the following): * Tumor-associated deformity of the SMV (superior mesenteric vein) or PV (portal vein) * Abutment of the SMV or PV \>= 180 degrees * Short-segment occlusion of the SMV or PV amenable to resection and venous reconstruction * Short-segment involvement of the hepatic artery or its branches amenable to resection and reconstruction * Abutment of the superior mesenteric artery (SMA) \< 180 degrees * Subjects must have measurable disease (by RECIST 1.1), defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral CT scan * No prior therapy for pancreatic cancer, including chemotherapy, radiation therapy, definitive surgery or investigational therapy * Members of all races and ethnic groups will be included * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 * Absolute neutrophil count \>= 1.5 K/cu mm * Platelets \>= 100 K/cu mm * Hemoglobin \>= 9.0 g/dL * Total bilirubin =\< 1.25 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal * Creatinine within normal institutional limits or creatinine clearance \>= 60 mL/min * No active prior malignancy within 3 years of registration (with the exception of non-melanoma skin cancer, in-situ cancers, or Rai stage 0 chronic lymphocytic leukemia \[CLL\]); if patient is disease free from a prior malignancy between 3-5 years, special consideration can be requested; in these cases, if the risk of recurrence at 5 years is less than 20%, and in the opinion of the investigator the prior malignancy will not affect the patient's outcome in light of newly diagnosed pancreatic cancer, the patient may be eligible; this will require principle investigator (PI) review and approval on a case by case basis, and approval will be documented in the medical record; all patients who have been disease free from a prior malignancy for at least 5 years will be eligible * No baseline peripheral sensory neuropathy \>= grade 2 * Women of child-bearing potential and men must be willing to use adequate contraception during the entire study and for 8 weeks following completion of all chemotherapy on study; this includes hormonal or barrier method, or abstinence * Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
* Subjects with locally advanced, unresectable primary tumors will not be eligible * This includes any of the following: * Abutment of the SMA \>= 180 degrees * Occlusion of the SMV or PV with insufficient normal vein above and below with which to perform venous reconstruction * Involvement of the hepatic artery with insufficient artery proximal and distal to perform reconstruction * Any prior therapy (chemotherapy, radiation or surgery) for pancreatic adenocarcinoma other than biliary decompression * Subjects who are receiving any other investigational agents * Subjects with known metastases * History of allergic reactions attributed to compounds of similar chemical or biologic composition to ABRAXANE or other agents used in the study * Active infection requiring intravenous antibiotics at the time of registration * 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 * History of interstitial lung disease, idiopathic pulmonary fibrosis, silicosis, sarcoidosis or connective tissue disorders (including rheumatoid arthritis and systemic lupus erythematosus) * Pregnant or breastfeeding women are excluded from this study * Subjects known to be human immunodeficiency virus (HIV)-positive, including those on combination antiretroviral therapy, are ineligible because of the potential for pharmacokinetic interactions with chemotherapy; in addition, these subjects are at increased risk of lethal infections when treated with marrow-suppressive therapy * Subjects with plastic biliary stents will be excluded; metal biliary stents are allowed and will not be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| R0 Resection Rate Defined as Macroscopically Complete Tumor Removal With Negative Microscopic Surgical Margins by Pathologic Assessment | At the time of surgery | The R0 resection rate, measured as the percent of participants achieving R0 resection among those who initiate study drug, will be computed with 95% confidence interval. A 2-sided binomial test will be used to determine whether the R0 resection rate is significantly greater than 0.37 at 10% significance level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 | From the first dose of study drug(s) until 28 days after last study intervention, up to approximately 3 years, 10 months | Frequency and severity of adverse events will be tabulated based on the actual treatment and the number of courses the patient receives. In particular, grade 3 and 4 toxicity rates will be computed and summarized for all patients received at least one dose of the assigned treatment. |
| Overall Survival Rate Defined as the Percentage of Subjects Alive at the 2 Year Time Point | From first dose of study drug until 2 years or time of death by any cause, which ever comes first. Participants are assessed every 3 months after completing study interventions. | The expected 2-year overall survival rate (%) will be reported with an associated 95% confidence interval for all enrolled participants (n = 19). Survival is assessed from the first dose of study drug(s) until the date of death due to any cause, up to two years. Participants known still alive at two-years will be censored at two years. Any participant lost to follow up during the two-year period will be censored on the last date known alive. |
| Overall Survival Rate Defined as the Percentage of Subjects Alive at the One Year Time Point | From first dose of study drug until 1 year or time of death by any cause, whichever comes first. Participants are assessed every 3 months after completing study interventions. | The expected 1-year overall survival rate (%) will be reported with an associated 95% confidence interval. Survival is assessed from the first dose of study drug(s) until the date of death due to any cause, up to one year. Participants known still alive at one-year will be censored at one year. Any participant lost to follow up during the one-year period will be censored on the last date known alive. |
| Relapse-free Survival Rate Defined as the Percentage of Subjects Who Are Without Recurrence or Death at One Year From Surgical Resection of the Primary Tumor | From time of resection until progression or death by any cause, within 1 year of resection. Participants are assessed by imaging every 3 months after completing study interventions. | The expected 1-year relapse-free survival rate (%) will be reported with an associated 95% confidence interval for those who undergo resection (n = 11). Resection-free survival is assessed from the time of resection until time of progression or death by any cause, up to one year. Participants known still alive and without progression at one-year post-resection will be censored at one year. Any participant lost to follow up during the one-year post-resection period will be censored on the last disease assessment date. Response is measured per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 using tumor imaging with CT. Changes in the largest diameter of tumor lesions (target lesions) and shortest diameter of malignant lymph nodes are assessed. Progression is at least 20% increase in sum of diameters of target lesions (referencing nadir sum of diameters) and an absolute increase of at least 5 mm. Presence of any new lesion is also considered progression disease. |
| Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Defined as the Percent of Subjects With Complete or Partial Disease Response as Confirmed Through Tumor Imaging With Computed Tomography (CT) | From first dose of study drug(s), with assessments at Staging 1 (approximately 2 months) and Staging 2 (approximately 5 months after first dose of study drug(s)). | The objective response rate (percentage of participants having complete response (CR) or partial response (PR)) will be computed with associated 95% confidence interval using the binomial exact method. Response is measured per RECIST 1.1 using tumor imaging with CT. Changes in the largest diameter of tumor lesions (target lesions) and shortest diameter of malignant lymphnodes are assessed. CR is the disappearance of all target lesions; any pathologic lymph nodes must show a reduction in short axis to \< 10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions using the baseline sum of diameters of target lesions as the reference level. |
Countries
United States
Participant flow
Pre-assignment details
20 participants enrolled who agreed to participate in the study following completion of the informed consent process. 19 started is the number of participants who were assigned to each Arm/Group. One subject withdrew prior to treatment resulting in a total of 19 subjects enrolled and started treatment.
Participants by arm
| Arm | Count |
|---|---|
| Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) PRE-OPERATIVE (NEOADJUVANT) CHEMOTHERAPY: Patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo IG-IMRT 5 days a week for 28 fractions and receive fluorouracil IV continuously on days 1-7 for 6 weeks.
SURGICAL RESECTION: Patients undergo surgery 4-10 weeks after the last dose of chemoradiation.
POST-OPERATIVE (ADUJUVANT) CHEMOTHERAPY: Beginning within 8-12 weeks after surgery, patients receive nab-paclitaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 4 additional courses in the absence of disease progression or unacceptable toxicity.
Fluorouracil: Given IV
Gemcitabine: Given IV
Image Guided Radiation Therapy: Undergo IG-IMRT
Intensity-Modulated Radiation Therapy: Undergo IG-IMRT
Laboratory Biomarker Analysis: Correlative studies
Nab-paclitaxel: Given IV
Therapeutic Conventional Surgery: Undergo surgery | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 5 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 14 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 68 years |
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0: Fully Active | 3 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 1: Restricted in physically strenuous activity but ambulatory and able to carry out light work | 16 Participants |
| Greatest Tumor diameter | 4.0 cm |
| Lymph node status Negative nodes on CT scan | 6 Participants |
| Lymph node status Positive nodes on CT scan | 13 Participants |
| Primary tumor site Body or neck | 5 Participants |
| Primary tumor site Head | 11 Participants |
| Primary tumor site Tail | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 19 participants |
| Serum CA 19-9 | 231 U/mL |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 9 Participants |
| Vascular involvement Arterial only | 6 Participants |
| Vascular involvement Both arterial and venous | 10 Participants |
| Vascular involvement No vascular involvement | 2 Participants |
| Vascular involvement Venous only | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 13 / 19 |
| other Total, other adverse events | 16 / 19 |
| serious Total, serious adverse events | 3 / 19 |
Outcome results
Primary
R0 Resection Rate Defined as Macroscopically Complete Tumor Removal With Negative Microscopic Surgical Margins by Pathologic Assessment
The R0 resection rate, measured as the percent of participants achieving R0 resection among those who initiate study drug, will be computed with 95% confidence interval. A 2-sided binomial test will be used to determine whether the R0 resection rate is significantly greater than 0.37 at 10% significance level.
Time frame: At the time of surgery
Population: Efficacy evaluable population is those who have received at least one administration of study drug and have at least one efficacy evaluation. Efficacy evaluable participants who fail to go onto surgery are counted as R0 failures (part of the denominator)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) | R0 Resection Rate Defined as Macroscopically Complete Tumor Removal With Negative Microscopic Surgical Margins by Pathologic Assessment | 42 percentage of participants |
Comparison: Study closed early due to lack of enrollment. Study expected to enrolled 44 evaluable patients to achieve 83% power using the 2-sided binomial test at 10% significance. Study enrolled only 19 evaluable patients, meaning the study was underpowered at \< 62%p-value: 0.40495% CI: [20, 67]2-sided exact binomial
Secondary
Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0
Frequency and severity of adverse events will be tabulated based on the actual treatment and the number of courses the patient receives. In particular, grade 3 and 4 toxicity rates will be computed and summarized for all patients received at least one dose of the assigned treatment.
Time frame: From the first dose of study drug(s) until 28 days after last study intervention, up to approximately 3 years, 10 months
Population: Selected adverse reactions with higher incidence (\>10%) or notable from package insert (nab-paclitaxel) during pre-operative gemcitabine \& nab-paclitaxel therapy per CTCAE terminology version 4.0. N=19
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) | Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 | Infections and infestations | 3 Adverse Events |
| Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) | Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 | Blood and Lymphatic system disorders | 4 Adverse Events |
| Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) | Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 | Gastrointestinal disorders | 24 Adverse Events |
| Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) | Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 | Hepatobiliary disorders | 1 Adverse Events |
| Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) | Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 | Investigations | 13 Adverse Events |
| Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) | Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 | Metabolism and nutrition disorders | 6 Adverse Events |
| Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) | Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 | Musculoskeletal and connective tissue disorders | 9 Adverse Events |
| Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) | Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 | Nervous system disorders | 15 Adverse Events |
| Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) | Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 | Psychiatric disorders | 2 Adverse Events |
| Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) | Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 | Respiratory, thoracic and mediastinal disorders | 7 Adverse Events |
| Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) | Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 | Skin and subcutaneous tissue disorders | 19 Adverse Events |
| Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) | Incidence of Toxicity According to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 4.0 | Vascular disorders | 3 Adverse Events |
Secondary
Overall Survival Rate Defined as the Percentage of Subjects Alive at the 2 Year Time Point
The expected 2-year overall survival rate (%) will be reported with an associated 95% confidence interval for all enrolled participants (n = 19). Survival is assessed from the first dose of study drug(s) until the date of death due to any cause, up to two years. Participants known still alive at two-years will be censored at two years. Any participant lost to follow up during the two-year period will be censored on the last date known alive.
Time frame: From first dose of study drug until 2 years or time of death by any cause, which ever comes first. Participants are assessed every 3 months after completing study interventions.
Population: All enrolled participants receiving at least one dose of study drug(s)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) | Overall Survival Rate Defined as the Percentage of Subjects Alive at the 2 Year Time Point | 41 percentage of participants |
Secondary
Overall Survival Rate Defined as the Percentage of Subjects Alive at the One Year Time Point
The expected 1-year overall survival rate (%) will be reported with an associated 95% confidence interval. Survival is assessed from the first dose of study drug(s) until the date of death due to any cause, up to one year. Participants known still alive at one-year will be censored at one year. Any participant lost to follow up during the one-year period will be censored on the last date known alive.
Time frame: From first dose of study drug until 1 year or time of death by any cause, whichever comes first. Participants are assessed every 3 months after completing study interventions.
Population: All enrolled participants receiving at least one dose of study drug(s)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) | Overall Survival Rate Defined as the Percentage of Subjects Alive at the One Year Time Point | 79 percentage of participants |
Secondary
Relapse-free Survival Rate Defined as the Percentage of Subjects Who Are Without Recurrence or Death at One Year From Surgical Resection of the Primary Tumor
The expected 1-year relapse-free survival rate (%) will be reported with an associated 95% confidence interval for those who undergo resection (n = 11). Resection-free survival is assessed from the time of resection until time of progression or death by any cause, up to one year. Participants known still alive and without progression at one-year post-resection will be censored at one year. Any participant lost to follow up during the one-year post-resection period will be censored on the last disease assessment date. Response is measured per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 using tumor imaging with CT. Changes in the largest diameter of tumor lesions (target lesions) and shortest diameter of malignant lymph nodes are assessed. Progression is at least 20% increase in sum of diameters of target lesions (referencing nadir sum of diameters) and an absolute increase of at least 5 mm. Presence of any new lesion is also considered progression disease.
Time frame: From time of resection until progression or death by any cause, within 1 year of resection. Participants are assessed by imaging every 3 months after completing study interventions.
Population: Study participants who receive at least one dose of study drug(s) and undergo surgical resection
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) | Relapse-free Survival Rate Defined as the Percentage of Subjects Who Are Without Recurrence or Death at One Year From Surgical Resection of the Primary Tumor | 64 percentage of participants |
Secondary
Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Defined as the Percent of Subjects With Complete or Partial Disease Response as Confirmed Through Tumor Imaging With Computed Tomography (CT)
The objective response rate (percentage of participants having complete response (CR) or partial response (PR)) will be computed with associated 95% confidence interval using the binomial exact method. Response is measured per RECIST 1.1 using tumor imaging with CT. Changes in the largest diameter of tumor lesions (target lesions) and shortest diameter of malignant lymphnodes are assessed. CR is the disappearance of all target lesions; any pathologic lymph nodes must show a reduction in short axis to \< 10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions using the baseline sum of diameters of target lesions as the reference level.
Time frame: From first dose of study drug(s), with assessments at Staging 1 (approximately 2 months) and Staging 2 (approximately 5 months after first dose of study drug(s)).
Population: Efficacy evaluable population, those receiving at least 1 dose of study drug(s) and having at least 1 efficacy evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Chemotherapy, Chemoradiation Therapy, Surgery) | Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Defined as the Percent of Subjects With Complete or Partial Disease Response as Confirmed Through Tumor Imaging With Computed Tomography (CT) | 21 percentage of participants |