Esophageal Cancer, GastroEsophageal Cancer
Conditions
Keywords
esophagus, gastroesophageal junction, T1-3N0-1, GE junction
Brief summary
This pilot phase II trial studies the therapeutic effects and side effects of CD40 agonistic monoclonal antibody APX005M when combined with chemotherapy and radiation therapy, and to see how well they work to reduce or remove esophageal or gastroesophageal (GE) cancers when given before surgery in treating patients with esophageal cancer or GE cancer than can be removed by surgery. APX005M is intended to stimulate the body's own immune system so that the immune cells can more effectively invade and destroy the tumor, adding to the benefits of the chemotherapy and radiation therapy. Drugs used in chemotherapy, such as carboplatin and paclitaxel, 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 APX005M, chemotherapy, 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: To assess the efficacy of this novel combination, as measured by the pathologic complete response (pCR) rate. Secondary Objectives: 1. To further characterize the safety and feasibility of combining APX005M with SOC chemoradiation (external beam radiation in daily fractions, with concurrent weekly low-dose carboplatin/paclitaxel) in the neoadjuvant setting for patients with resectable esophageal and GE junction cancers. 2. To assess the efficacy of combining APX005M with SOC chemoradiation as measured by rates of R0 resection (microscopically negative margins, i.e., no tumor remains following surgery); and radiographic/metabolic response to neoadjuvant treatment on CT-PET. Exploratory Objectives: 1. To identify possible predictive molecular or immune-based efficacy biomarkers for this novel combination. 2. To characterize and assess overall survival.
Interventions
DRUGAPX005M
APX005M IV infusion
RADIATIONRadiation Therapy
Radiation therapy, total dose 5040cGy in 180cGy fractions
DRUGPaclitaxel
Paclitaxel IV infusion
DRUGCarboplatin
Carboplatin IV infusion
PROCEDURESurgical resection of tumor
Surgical removal of the tumor will occur between weeks 10-17
Sponsors
Apexigen America, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Non-comparative, open-label pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years of age. 2. Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the esophagus or GE junction. 3. Surgically resectable (T1-3 Nx preferably by endoscopic ultrasound \[EUS\]). (Excluded: T1N0 tumors, cervical esophageal location, tumors invading the tracheobronchial tree or with fistula, distant disease that cannot be included in the radiation field or be resected at the time of esophagectomy). 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 5. Adequate hematological, renal, and hepatic parameters.
Exclusion criteria
1. Any history of or current hematologic malignancy. 2. History of a second primary cancer is allowed in the event the cancer is curatively resected and there is no evidence of recurrence/metastatic disease x 1 year. Subjects who have a history of cervical or breast carcinoma in situ, localized prostate cancer, adequately treated basal cell or squamous cell carcinoma of the skin, or superficial bladder tumors \[Ta, Tis & T1\] are also allowed. 3. Major surgery within 4 weeks of first dose of investigational product. 4. Prior or concurrent treatment with any anticancer agent for the same cancer diagnosis. 5. Prior exposure to any immuno-oncology agents, including CD40/PD-1/PD-L1/CTLA-4 inhibitors (if any ambiguity, should be discussed with study principal investigator). 6. History of bone marrow transplantation. 7. History of autoimmune disorders with the exception of vitiligo or autoimmune thyroid disorders. 8. Chronic steroid dependency (prednisone equivalent \> 10 mg/day). Any steroid use should be discontinued at least 2 weeks prior to initiation of study treatment. 9. Congestive heart failure (New York Heart Association Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 6 months before first dose. 10. Known human immunodeficiency virus (HIV) infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic Complete Response (pCR) Rate (%) Overall | At time of surgery, up to a maximum of 261 days | The pCR was defined as post-neoadjuvant pathologic tumour, node, metastasis (ypTNM) (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator. * T0: No evidence of primary tumor. * N0: Cancer has not spread to nearby lymph nodes. An exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%. |
| pCR Rate (%) by Baseline Histologic Subgroup | At time of surgery, up to a maximum of 261 days | The pCR was defined as ypTNM (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator. An exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%. |
| pCR Rate (%) by Baseline Tumor Location Subgroup | At time of surgery, up to a maximum of 261 days | The pCR was defined as ypTNM (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator. An exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%. |
| pCR Rate (%) by Steroid Use Subgroup | At time of surgery, up to a maximum of 261 days | The pCR was defined as ypTNM (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator. Steroids use: Yes was defined as participants with any steroid (ATC2 class corticosteroids for systemic use) from within 30 days of the first dose of sotigalimab to up to 7 days after the first dose and participants not fulfilling previous requirements are defined as Steroids use: No. An exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%. |
| pCR Rate (%) by Surgery Subgroup | At time of surgery, up to a maximum of 261 days | The pCR was defined as ypTNM (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator. The subgroup of participants who had surgery before or at 16/17 weeks were defined as start of study treatment to surgery date from the surgical resection form, less than or equal to 17 weeks (119 days = 17 weeks \* 7 days) or participants who were scheduled to have surgery but had their procedure aborted due to progressive disease at the time of the procedure or immediately before and did not have surgery because of metastasis. The subgroup of participants who had surgery after Week 17 were defined as start of study treatment to surgery date from the surgical resection form, greater than 17 weeks. An exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | At time of surgery, up to a maximum of 261 days, 3 and 6 months post-operatively, and End of Study Visit (maximum of 6 months post-operatively) | Response was adjudicated by the investigator; based on combination of change in wall thickening; size of regional lymph nodes; and metabolic activity of involved areas. As the population does not typically have measurable disease by RECIST, radiographic/metabolic response was described in qualitative terms (responding/ stable, unchanged/ progressing/ not evaluable). |
| Rate (%) of R0 Resection Overall | At time of surgery, up to a maximum of 261 days | R0 was defined as the absence of gross and microscopic tumor involvement in the surgical margins i.e., no tumor remains following surgery. Rate of R0 resection was defined as the percentage of participants who achieved R0 following surgical resection. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to approximately 20 weeks | TEAEs were defined as adverse events which started on or after the first infusion of study treatment (Carboplatin/Paclitaxel/Sotigalimab/Radiotherapy) until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first. Laboratory values that were considered clinically significant were reported as adverse events. |
| Rate (%) of R0 Resection by Baseline Histologic Subgroup | At time of surgery, up to a maximum of 261 days | R0 was defined as the absence of gross and microscopic tumor involvement in the surgical margins i.e., no tumor remains following surgery. Rate of R0 resection was defined as the percentage of participants who achieved R0 following surgical resection. |
| Pathologic Stage at Time of Surgery | At time of surgery, up to a maximum of 261 days | Pathologic staging was assessed via ypTNM (after chemoRT and surgery): * Tumor Stage (TX, T0, T1, T1a, T1b, T2, T3, T4, T4a, T4b) refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it had grown into the wall of the esophagus. * Node Stage (NX, N0, N1, N2, N3) refers to the number and location of lymph nodes that cancer has spread to. The higher the number after the N, the more lymph nodes that contained cancer cells. * Metastasis Stage (M0, M1) refers to whether the cancer had not spread (M0) or spread (M1) to other parts of the body. * Stage group (0, I, IA, IB, II, IIA, IIB, III, IIIA, IIIB, IV, IVA, IVB) are based on the TNM stages detailed above. The higher the number, the more advanced the cancer was. For each category, a lower stage/group represents a better outcome. |
| Radiographic/Metabolic Response to Neoadjuvant Treatment on Computed Tomography (CT)/CT-Positron Emission Tomography (PET) (CT-PET) Overall | At time of surgery, up to a maximum of 261 days, 3 and 6 months post-operatively, and End of Study Visit (maximum of 6 months post-operatively) | Response was adjudicated by the investigator; based on combination of change in wall thickening; size of regional lymph nodes; and metabolic activity of involved areas. As the population does not typically have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST), radiographic/metabolic response was described in qualitative terms (responding/ stable, unchanged/ progressing/ not evaluable). |
| Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | At time of surgery, up to a maximum of 261 days, 3 and 6 months post-operatively, and End of Study Visit (maximum of 6 months post-operatively) | Response was adjudicated by the investigator; based on combination of change in wall thickening; size of regional lymph nodes; and metabolic activity of involved areas. As the population does not typically have measurable disease by RECIST, radiographic/metabolic response was described in qualitative terms (responding/ stable, unchanged/ progressing/ not evaluable). |
Countries
United States
Participant flow
Recruitment details
A total of 34 participants were eligible for the study, of which 33 received treatment in the study, in the United States between October 2017 and February 2023.
Pre-assignment details
The study consisted of: * Screening Period (within 28 days of Treatment Period Day 1). * Treatment Period (Weeks 1-6) sotigalimab with standard-of-care (SOC) chemoradiation (chemoRT) consisting of external beam radiation in daily fractions, with concurrent weekly low-dose carboplatin/paclitaxel. * Post-treatment Period inc. surgery (Weeks 7-17). * Post-operative Follow-up Period (Months 1, 3, and 6 post-operatively). * Overall Survival Follow-up Period (every 3 months for 18 months).
Participants by arm
| Arm | Count |
|---|---|
| Sotigalimab With SOC ChemoRT Participants received SOC chemoRT, consisting of:
* External beam radiation in daily fractions (28 fractions) from Weeks 1-6, administered once per day up to 5 days/week.
* Carboplatin (AUC = 2) and paclitaxel (50 mg/m\^2) chemotherapy IV over 1 hour, once weekly, from Weeks 1-5.
The participants also received concurrent 0.3 mg/kg sotigalimab IV over 1 hour, once weekly, on Weeks 1, 2, 4, and 6 (2-3 days after chemoRT).
Surgical resection of the tumor was planned to be performed from Week 10 up to approximately Week 17, as indicated in the protocol amendment under which each participant was enrolled. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Confirmed Radiographic Disease Progression | 4 |
| Overall Study | Death | 2 |
| Overall Study | Miscellaneous | 1 |
| Overall Study | Non-Compliance With Study Treatment or Procedure Requirements | 3 |
| Overall Study | Participant or Legal Representative Withdraws Consent | 1 |
| Overall Study | Physician Decision, other than adverse event (AE) | 9 |
Baseline characteristics
| Characteristic | Sotigalimab With SOC ChemoRT |
|---|---|
| Age, Continuous | 64.5 years STANDARD_DEVIATION 9.17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants |
| Race/Ethnicity, Customized Black or African | 1 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Race/Ethnicity, Customized White | 25 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 26 Participants |
| Tumor Histology Adenocarcinoma | 25 Participants |
| Tumor Histology Squamous Cell Carcinoma | 8 Participants |
| Tumor Location GE Junction | 15 Participants |
| Tumor Location Non-GE Junction | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 33 |
| other Total, other adverse events | 33 / 33 |
| serious Total, serious adverse events | 16 / 33 |
Outcome results
Primary
Pathologic Complete Response (pCR) Rate (%) Overall
The pCR was defined as post-neoadjuvant pathologic tumour, node, metastasis (ypTNM) (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator. * T0: No evidence of primary tumor. * N0: Cancer has not spread to nearby lymph nodes. An exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%.
Time frame: At time of surgery, up to a maximum of 261 days
Population: Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sotigalimab With SOC ChemoRT | Pathologic Complete Response (pCR) Rate (%) Overall | 37.9 percentage of participants |
Primary
pCR Rate (%) by Baseline Histologic Subgroup
The pCR was defined as ypTNM (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator. An exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%.
Time frame: At time of surgery, up to a maximum of 261 days
Population: Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sotigalimab With SOC ChemoRT | pCR Rate (%) by Baseline Histologic Subgroup | Squamous Cell Carcinoma | 60.0 percentage of participants |
| Sotigalimab With SOC ChemoRT | pCR Rate (%) by Baseline Histologic Subgroup | Adenocarcinoma | 33.3 percentage of participants |
Primary
pCR Rate (%) by Baseline Tumor Location Subgroup
The pCR was defined as ypTNM (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator. An exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%.
Time frame: At time of surgery, up to a maximum of 261 days
Population: Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sotigalimab With SOC ChemoRT | pCR Rate (%) by Baseline Tumor Location Subgroup | GE Junction | 28.6 percentage of participants |
| Sotigalimab With SOC ChemoRT | pCR Rate (%) by Baseline Tumor Location Subgroup | Non-GE Junction | 46.7 percentage of participants |
Primary
pCR Rate (%) by Steroid Use Subgroup
The pCR was defined as ypTNM (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator. Steroids use: Yes was defined as participants with any steroid (ATC2 class corticosteroids for systemic use) from within 30 days of the first dose of sotigalimab to up to 7 days after the first dose and participants not fulfilling previous requirements are defined as Steroids use: No. An exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%.
Time frame: At time of surgery, up to a maximum of 261 days
Population: Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sotigalimab With SOC ChemoRT | pCR Rate (%) by Steroid Use Subgroup | Steroid Use: Yes | 31.3 percentage of participants |
| Sotigalimab With SOC ChemoRT | pCR Rate (%) by Steroid Use Subgroup | Steroid Use: No | 46.2 percentage of participants |
Primary
pCR Rate (%) by Surgery Subgroup
The pCR was defined as ypTNM (after chemoRT; after surgery) with T0, N0 stages. pCR rate was defined as the percentage of participants who achieved a pCR at surgery, as assessed by the Investigator. The subgroup of participants who had surgery before or at 16/17 weeks were defined as start of study treatment to surgery date from the surgical resection form, less than or equal to 17 weeks (119 days = 17 weeks \* 7 days) or participants who were scheduled to have surgery but had their procedure aborted due to progressive disease at the time of the procedure or immediately before and did not have surgery because of metastasis. The subgroup of participants who had surgery after Week 17 were defined as start of study treatment to surgery date from the surgical resection form, greater than 17 weeks. An exact Clopper-Pearson lower 95% confidence limit was used to test the null hypothesis that the pCR rate is ≤30%.
Time frame: At time of surgery, up to a maximum of 261 days
Population: Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sotigalimab With SOC ChemoRT | pCR Rate (%) by Surgery Subgroup | Surgery Before or at Week 16-17 | 28.6 percentage of participants |
| Sotigalimab With SOC ChemoRT | pCR Rate (%) by Surgery Subgroup | Surgery After Week 17 | 62.5 percentage of participants |
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAEs were defined as adverse events which started on or after the first infusion of study treatment (Carboplatin/Paclitaxel/Sotigalimab/Radiotherapy) until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first. Laboratory values that were considered clinically significant were reported as adverse events.
Time frame: Up to approximately 20 weeks
Population: Safety Population: All participants who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sotigalimab With SOC ChemoRT | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 33 Participants |
Secondary
Pathologic Stage at Time of Surgery
Pathologic staging was assessed via ypTNM (after chemoRT and surgery): * Tumor Stage (TX, T0, T1, T1a, T1b, T2, T3, T4, T4a, T4b) refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it had grown into the wall of the esophagus. * Node Stage (NX, N0, N1, N2, N3) refers to the number and location of lymph nodes that cancer has spread to. The higher the number after the N, the more lymph nodes that contained cancer cells. * Metastasis Stage (M0, M1) refers to whether the cancer had not spread (M0) or spread (M1) to other parts of the body. * Stage group (0, I, IA, IB, II, IIA, IIB, III, IIIA, IIIB, IV, IVA, IVB) are based on the TNM stages detailed above. The higher the number, the more advanced the cancer was. For each category, a lower stage/group represents a better outcome.
Time frame: At time of surgery, up to a maximum of 261 days
Population: Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sotigalimab With SOC ChemoRT | Pathologic Stage at Time of Surgery | Node Stage: N0 | 21 Participants |
| Sotigalimab With SOC ChemoRT | Pathologic Stage at Time of Surgery | Node Stage: N1 | 3 Participants |
| Sotigalimab With SOC ChemoRT | Pathologic Stage at Time of Surgery | Metastasis Stage: M0 | 27 Participants |
| Sotigalimab With SOC ChemoRT | Pathologic Stage at Time of Surgery | Stage Group: I | 2 Participants |
| Sotigalimab With SOC ChemoRT | Pathologic Stage at Time of Surgery | Stage Group: II | 6 Participants |
| Sotigalimab With SOC ChemoRT | Pathologic Stage at Time of Surgery | Tumor Stage: Missing | 2 Participants |
| Sotigalimab With SOC ChemoRT | Pathologic Stage at Time of Surgery | Tumor Stage: T0 | 12 Participants |
| Sotigalimab With SOC ChemoRT | Pathologic Stage at Time of Surgery | Tumor Stage: T1a | 1 Participants |
| Sotigalimab With SOC ChemoRT | Pathologic Stage at Time of Surgery | Tumor Stage: T2 | 5 Participants |
| Sotigalimab With SOC ChemoRT | Pathologic Stage at Time of Surgery | Tumor Stage: T3 | 9 Participants |
| Sotigalimab With SOC ChemoRT | Pathologic Stage at Time of Surgery | Node Stage: Missing | 2 Participants |
| Sotigalimab With SOC ChemoRT | Pathologic Stage at Time of Surgery | Node Stage: N2 | 2 Participants |
| Sotigalimab With SOC ChemoRT | Pathologic Stage at Time of Surgery | Node Stage: N3 | 1 Participants |
| Sotigalimab With SOC ChemoRT | Pathologic Stage at Time of Surgery | Metastasis Stage: Missing | 2 Participants |
| Sotigalimab With SOC ChemoRT | Pathologic Stage at Time of Surgery | Stage Group: Missing | 13 Participants |
| Sotigalimab With SOC ChemoRT | Pathologic Stage at Time of Surgery | Stage Group: IA | 1 Participants |
| Sotigalimab With SOC ChemoRT | Pathologic Stage at Time of Surgery | Stage Group: III | 1 Participants |
| Sotigalimab With SOC ChemoRT | Pathologic Stage at Time of Surgery | Stage Group: IIIA | 2 Participants |
| Sotigalimab With SOC ChemoRT | Pathologic Stage at Time of Surgery | Stage Group: IIIB | 3 Participants |
| Sotigalimab With SOC ChemoRT | Pathologic Stage at Time of Surgery | Stage Group: IVA | 1 Participants |
Secondary
Radiographic/Metabolic Response to Neoadjuvant Treatment on Computed Tomography (CT)/CT-Positron Emission Tomography (PET) (CT-PET) Overall
Response was adjudicated by the investigator; based on combination of change in wall thickening; size of regional lymph nodes; and metabolic activity of involved areas. As the population does not typically have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST), radiographic/metabolic response was described in qualitative terms (responding/ stable, unchanged/ progressing/ not evaluable).
Time frame: At time of surgery, up to a maximum of 261 days, 3 and 6 months post-operatively, and End of Study Visit (maximum of 6 months post-operatively)
Population: Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease. Participants with data available at each time point are presented. Participants included at End of Study Visit discontinued prior to completion of Postoperative Follow-up/Month 6.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on Computed Tomography (CT)/CT-Positron Emission Tomography (PET) (CT-PET) Overall | At Time of Surgery | Missing | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on Computed Tomography (CT)/CT-Positron Emission Tomography (PET) (CT-PET) Overall | At Time of Surgery | Responding | 22 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on Computed Tomography (CT)/CT-Positron Emission Tomography (PET) (CT-PET) Overall | At Time of Surgery | Stable/Unchanged | 5 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on Computed Tomography (CT)/CT-Positron Emission Tomography (PET) (CT-PET) Overall | At Time of Surgery | Progressing | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on Computed Tomography (CT)/CT-Positron Emission Tomography (PET) (CT-PET) Overall | At Time of Surgery | Not Evaluable | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on Computed Tomography (CT)/CT-Positron Emission Tomography (PET) (CT-PET) Overall | Postoperative Follow-up/Month 3 | Missing | 3 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on Computed Tomography (CT)/CT-Positron Emission Tomography (PET) (CT-PET) Overall | Postoperative Follow-up/Month 3 | Responding | 9 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on Computed Tomography (CT)/CT-Positron Emission Tomography (PET) (CT-PET) Overall | Postoperative Follow-up/Month 3 | Stable/Unchanged | 2 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on Computed Tomography (CT)/CT-Positron Emission Tomography (PET) (CT-PET) Overall | Postoperative Follow-up/Month 3 | Progressing | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on Computed Tomography (CT)/CT-Positron Emission Tomography (PET) (CT-PET) Overall | Postoperative Follow-up/Month 3 | Not Evaluable | 3 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on Computed Tomography (CT)/CT-Positron Emission Tomography (PET) (CT-PET) Overall | Postoperative Follow-up/Month 6 | Missing | 3 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on Computed Tomography (CT)/CT-Positron Emission Tomography (PET) (CT-PET) Overall | Postoperative Follow-up/Month 6 | Responding | 6 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on Computed Tomography (CT)/CT-Positron Emission Tomography (PET) (CT-PET) Overall | Postoperative Follow-up/Month 6 | Stable/Unchanged | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on Computed Tomography (CT)/CT-Positron Emission Tomography (PET) (CT-PET) Overall | Postoperative Follow-up/Month 6 | Progressing | 2 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on Computed Tomography (CT)/CT-Positron Emission Tomography (PET) (CT-PET) Overall | Postoperative Follow-up/Month 6 | Not Evaluable | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on Computed Tomography (CT)/CT-Positron Emission Tomography (PET) (CT-PET) Overall | End of Study Visit | Missing | 2 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on Computed Tomography (CT)/CT-Positron Emission Tomography (PET) (CT-PET) Overall | End of Study Visit | Responding | 2 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on Computed Tomography (CT)/CT-Positron Emission Tomography (PET) (CT-PET) Overall | End of Study Visit | Stable/Unchanged | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on Computed Tomography (CT)/CT-Positron Emission Tomography (PET) (CT-PET) Overall | End of Study Visit | Progressing | 3 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on Computed Tomography (CT)/CT-Positron Emission Tomography (PET) (CT-PET) Overall | End of Study Visit | Not Evaluable | 2 Participants |
Secondary
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup
Response was adjudicated by the investigator; based on combination of change in wall thickening; size of regional lymph nodes; and metabolic activity of involved areas. As the population does not typically have measurable disease by RECIST, radiographic/metabolic response was described in qualitative terms (responding/ stable, unchanged/ progressing/ not evaluable).
Time frame: At time of surgery, up to a maximum of 261 days, 3 and 6 months post-operatively, and End of Study Visit (maximum of 6 months post-operatively)
Population: Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease. Participants with data available at each time point are presented. Participants included at End of Study Visit discontinued prior to completion of Postoperative Follow-up/Month 6.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Squamous Cell Carcinoma: At Time of Surgery | Missing | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Squamous Cell Carcinoma: At Time of Surgery | Responding | 5 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Squamous Cell Carcinoma: At Time of Surgery | Stable/Unchanged | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Squamous Cell Carcinoma: At Time of Surgery | Progressing | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Squamous Cell Carcinoma: At Time of Surgery | Not Evaluable | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Squamous Cell Carcinoma: Postoperative Follow-up/Month 3 | Missing | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Squamous Cell Carcinoma: Postoperative Follow-up/Month 3 | Responding | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Squamous Cell Carcinoma: Postoperative Follow-up/Month 3 | Stable/Unchanged | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Squamous Cell Carcinoma: Postoperative Follow-up/Month 3 | Progressing | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Squamous Cell Carcinoma: Postoperative Follow-up/Month 3 | Not Evaluable | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Squamous Cell Carcinoma: Postoperative Follow-up/Month 6 | Missing | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Squamous Cell Carcinoma: Postoperative Follow-up/Month 6 | Responding | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Squamous Cell Carcinoma: Postoperative Follow-up/Month 6 | Stable/Unchanged | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Squamous Cell Carcinoma: Postoperative Follow-up/Month 6 | Progressing | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Squamous Cell Carcinoma: Postoperative Follow-up/Month 6 | Not Evaluable | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Squamous Cell Carcinoma: End of Study Visit | Missing | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Squamous Cell Carcinoma: End of Study Visit | Responding | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Squamous Cell Carcinoma: End of Study Visit | Stable/Unchanged | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Squamous Cell Carcinoma: End of Study Visit | Progressing | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Squamous Cell Carcinoma: End of Study Visit | Not Evaluable | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Adenocarcinoma: At Time of Surgery | Missing | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Adenocarcinoma: At Time of Surgery | Responding | 17 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Adenocarcinoma: At Time of Surgery | Stable/Unchanged | 5 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Adenocarcinoma: At Time of Surgery | Progressing | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Adenocarcinoma: At Time of Surgery | Not Evaluable | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Adenocarcinoma: Postoperative Follow-up/Month 3 | Missing | 2 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Adenocarcinoma: Postoperative Follow-up/Month 3 | Responding | 8 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Adenocarcinoma: Postoperative Follow-up/Month 3 | Stable/Unchanged | 2 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Adenocarcinoma: Postoperative Follow-up/Month 3 | Progressing | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Adenocarcinoma: Postoperative Follow-up/Month 3 | Not Evaluable | 2 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Adenocarcinoma: Postoperative Follow-up/Month 6 | Missing | 3 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Adenocarcinoma: Postoperative Follow-up/Month 6 | Responding | 5 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Adenocarcinoma: Postoperative Follow-up/Month 6 | Stable/Unchanged | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Adenocarcinoma: Postoperative Follow-up/Month 6 | Progressing | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Adenocarcinoma: Postoperative Follow-up/Month 6 | Not Evaluable | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Adenocarcinoma: End of Study Visit | Missing | 2 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Adenocarcinoma: End of Study Visit | Responding | 2 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Adenocarcinoma: End of Study Visit | Stable/Unchanged | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Adenocarcinoma: End of Study Visit | Progressing | 2 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup | Adenocarcinoma: End of Study Visit | Not Evaluable | 2 Participants |
Secondary
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup
Response was adjudicated by the investigator; based on combination of change in wall thickening; size of regional lymph nodes; and metabolic activity of involved areas. As the population does not typically have measurable disease by RECIST, radiographic/metabolic response was described in qualitative terms (responding/ stable, unchanged/ progressing/ not evaluable).
Time frame: At time of surgery, up to a maximum of 261 days, 3 and 6 months post-operatively, and End of Study Visit (maximum of 6 months post-operatively)
Population: Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease. Participants with data available at each time point are presented. Participants included at End of Study Visit discontinued prior to completion of Postoperative Follow-up/Month 6.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | GE Junction: At Time of Surgery | Missing | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | GE Junction: At Time of Surgery | Responding | 10 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | GE Junction: At Time of Surgery | Stable/Unchanged | 3 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | GE Junction: At Time of Surgery | Progressing | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | GE Junction: At Time of Surgery | Not Evaluable | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | GE Junction: Postoperative Follow-up/Month 3 | Missing | 2 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | GE Junction: Postoperative Follow-up/Month 3 | Responding | 4 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | GE Junction: Postoperative Follow-up/Month 3 | Stable/Unchanged | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | GE Junction: Postoperative Follow-up/Month 3 | Progressing | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | GE Junction: Postoperative Follow-up/Month 3 | Not Evaluable | 2 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | GE Junction: Postoperative Follow-up/Month 6 | Missing | 2 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | GE Junction: Postoperative Follow-up/Month 6 | Responding | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | GE Junction: Postoperative Follow-up/Month 6 | Stable/Unchanged | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | GE Junction: Postoperative Follow-up/Month 6 | Progressing | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | GE Junction: Postoperative Follow-up/Month 6 | Not Evaluable | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | GE Junction: End of Study Visit | Missing | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | GE Junction: End of Study Visit | Responding | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | GE Junction: End of Study Visit | Stable/Unchanged | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | GE Junction: End of Study Visit | Progressing | 3 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | GE Junction: End of Study Visit | Not Evaluable | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | Non-GE Junction: At Time of Surgery | Missing | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | Non-GE Junction: At Time of Surgery | Responding | 12 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | Non-GE Junction: At Time of Surgery | Stable/Unchanged | 2 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | Non-GE Junction: At Time of Surgery | Progressing | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | Non-GE Junction: At Time of Surgery | Not Evaluable | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | Non-GE Junction: Postoperative Follow-up/Month 3 | Missing | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | Non-GE Junction: Postoperative Follow-up/Month 3 | Responding | 5 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | Non-GE Junction: Postoperative Follow-up/Month 3 | Stable/Unchanged | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | Non-GE Junction: Postoperative Follow-up/Month 3 | Progressing | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | Non-GE Junction: Postoperative Follow-up/Month 3 | Not Evaluable | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | Non-GE Junction: Postoperative Follow-up/Month 6 | Missing | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | Non-GE Junction: Postoperative Follow-up/Month 6 | Responding | 5 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | Non-GE Junction: Postoperative Follow-up/Month 6 | Stable/Unchanged | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | Non-GE Junction: Postoperative Follow-up/Month 6 | Progressing | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | Non-GE Junction: Postoperative Follow-up/Month 6 | Not Evaluable | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | Non-GE Junction: End of Study Visit | Missing | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | Non-GE Junction: End of Study Visit | Responding | 1 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | Non-GE Junction: End of Study Visit | Stable/Unchanged | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | Non-GE Junction: End of Study Visit | Progressing | 0 Participants |
| Sotigalimab With SOC ChemoRT | Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup | Non-GE Junction: End of Study Visit | Not Evaluable | 2 Participants |
Secondary
Rate (%) of R0 Resection by Baseline Histologic Subgroup
R0 was defined as the absence of gross and microscopic tumor involvement in the surgical margins i.e., no tumor remains following surgery. Rate of R0 resection was defined as the percentage of participants who achieved R0 following surgical resection.
Time frame: At time of surgery, up to a maximum of 261 days
Population: Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sotigalimab With SOC ChemoRT | Rate (%) of R0 Resection by Baseline Histologic Subgroup | Squamous Cell Carcinoma | 100 percentage of participants |
| Sotigalimab With SOC ChemoRT | Rate (%) of R0 Resection by Baseline Histologic Subgroup | Adenocarcinoma | 83.3 percentage of participants |
Secondary
Rate (%) of R0 Resection Overall
R0 was defined as the absence of gross and microscopic tumor involvement in the surgical margins i.e., no tumor remains following surgery. Rate of R0 resection was defined as the percentage of participants who achieved R0 following surgical resection.
Time frame: At time of surgery, up to a maximum of 261 days
Population: Efficacy Population: All participants who were eligible, received neoadjuvant sotigalimab and chemoRT followed by surgery, or had their planned surgery aborted due to the discovery of progressive disease.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sotigalimab With SOC ChemoRT | Rate (%) of R0 Resection Overall | 86.2 percentage of participants |