Trial Outcomes & Findings for APX005M With Concurrent Chemoradiation for Resectable Esophageal and Gastroesophageal Junction Cancers (NCT NCT03165994)

NCT ID: NCT03165994

Last Updated: 2024-05-02

Results Overview

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%.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 34 participants
• Primary outcome timeframe: At time of surgery, up to a maximum of 261 days
• Results posted on: 2024-05-02

Participant Flow

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.

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).

Participant milestones

Measure	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 (area under the carboplatin plasma concentration versus time curve \[AUC\] = 2) and paclitaxel (50 mg/m\^2) chemotherapy intravenously (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.
Overall Study STARTED	33
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Measure	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 (area under the carboplatin plasma concentration versus time curve \[AUC\] = 2) and paclitaxel (50 mg/m\^2) chemotherapy intravenously (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.
Overall Study Confirmed Radiographic Disease Progression	4
Overall Study Death	2
Overall Study Non-Compliance With Study Treatment or Procedure Requirements	3
Overall Study Physician Decision, other than adverse event (AE)	9
Overall Study Participant or Legal Representative Withdraws Consent	1
Overall Study Miscellaneous	1

Baseline Characteristics

APX005M With Concurrent Chemoradiation for Resectable Esophageal and Gastroesophageal Junction Cancers

Baseline characteristics by cohort

Measure	Sotigalimab With SOC ChemoRT n=33 Participants 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.
Age, Continuous	64.5 years STANDARD_DEVIATION 9.17 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized White	25 Participants n=5 Participants
Race/Ethnicity, Customized Black or African	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants
Tumor Histology Squamous Cell Carcinoma	8 Participants n=5 Participants
Tumor Histology Adenocarcinoma	25 Participants n=5 Participants
Tumor Location GE Junction	15 Participants n=5 Participants
Tumor Location Non-GE Junction	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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%.

Outcome measures

Measure

Sotigalimab With SOC ChemoRT n=29 Participants 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.

Pathologic Complete Response (pCR) Rate (%) Overall

37.9 percentage of participants Interval 20.7 to 57.7

PRIMARY outcome

Timeframe: 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.

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%.

Outcome measures

Measure	Sotigalimab With SOC ChemoRT n=29 Participants 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.
pCR Rate (%) by Baseline Histologic Subgroup Squamous Cell Carcinoma	60.0 percentage of participants Interval 14.7 to 94.7
pCR Rate (%) by Baseline Histologic Subgroup Adenocarcinoma	33.3 percentage of participants Interval 15.6 to 55.3

PRIMARY outcome

Timeframe: 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.

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%.

Outcome measures

Measure	Sotigalimab With SOC ChemoRT n=29 Participants 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.
pCR Rate (%) by Baseline Tumor Location Subgroup GE Junction	28.6 percentage of participants Interval 8.4 to 58.1
pCR Rate (%) by Baseline Tumor Location Subgroup Non-GE Junction	46.7 percentage of participants Interval 21.3 to 73.4

PRIMARY outcome

Timeframe: 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.

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%.

Outcome measures

Measure	Sotigalimab With SOC ChemoRT n=29 Participants 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.
pCR Rate (%) by Steroid Use Subgroup Steroid Use: Yes	31.3 percentage of participants Interval 11.0 to 58.7
pCR Rate (%) by Steroid Use Subgroup Steroid Use: No	46.2 percentage of participants Interval 19.2 to 74.9

PRIMARY outcome

Timeframe: 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.

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%.

Outcome measures

Measure	Sotigalimab With SOC ChemoRT n=29 Participants 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.
pCR Rate (%) by Surgery Subgroup Surgery Before or at Week 16-17	28.6 percentage of participants Interval 11.3 to 52.2
pCR Rate (%) by Surgery Subgroup Surgery After Week 17	62.5 percentage of participants Interval 24.5 to 91.5

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure

Sotigalimab With SOC ChemoRT n=29 Participants 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.

Rate (%) of R0 Resection Overall

86.2 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Sotigalimab With SOC ChemoRT n=29 Participants 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.
Rate (%) of R0 Resection by Baseline Histologic Subgroup Squamous Cell Carcinoma	100 percentage of participants
Rate (%) of R0 Resection by Baseline Histologic Subgroup Adenocarcinoma	83.3 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Sotigalimab With SOC ChemoRT n=29 Participants 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.
Pathologic Stage at Time of Surgery Tumor Stage: Missing	2 Participants
Pathologic Stage at Time of Surgery Tumor Stage: T0	12 Participants
Pathologic Stage at Time of Surgery Tumor Stage: T1a	1 Participants
Pathologic Stage at Time of Surgery Tumor Stage: T2	5 Participants
Pathologic Stage at Time of Surgery Tumor Stage: T3	9 Participants
Pathologic Stage at Time of Surgery Node Stage: Missing	2 Participants
Pathologic Stage at Time of Surgery Node Stage: N0	21 Participants
Pathologic Stage at Time of Surgery Node Stage: N1	3 Participants
Pathologic Stage at Time of Surgery Node Stage: N2	2 Participants
Pathologic Stage at Time of Surgery Node Stage: N3	1 Participants
Pathologic Stage at Time of Surgery Metastasis Stage: Missing	2 Participants
Pathologic Stage at Time of Surgery Metastasis Stage: M0	27 Participants
Pathologic Stage at Time of Surgery Stage Group: Missing	13 Participants
Pathologic Stage at Time of Surgery Stage Group: I	2 Participants
Pathologic Stage at Time of Surgery Stage Group: IA	1 Participants
Pathologic Stage at Time of Surgery Stage Group: II	6 Participants
Pathologic Stage at Time of Surgery Stage Group: III	1 Participants
Pathologic Stage at Time of Surgery Stage Group: IIIA	2 Participants
Pathologic Stage at Time of Surgery Stage Group: IIIB	3 Participants
Pathologic Stage at Time of Surgery Stage Group: IVA	1 Participants

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Sotigalimab With SOC ChemoRT n=29 Participants 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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 outcome

Timeframe: 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.

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).

Outcome measures

Measure	Sotigalimab With SOC ChemoRT n=29 Participants 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.
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Squamous Cell Carcinoma: At Time of Surgery · Missing	0 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Squamous Cell Carcinoma: At Time of Surgery · Responding	5 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Squamous Cell Carcinoma: At Time of Surgery · Stable/Unchanged	0 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Squamous Cell Carcinoma: At Time of Surgery · Progressing	0 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Squamous Cell Carcinoma: At Time of Surgery · Not Evaluable	0 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Squamous Cell Carcinoma: Postoperative Follow-up/Month 3 · Missing	1 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Squamous Cell Carcinoma: Postoperative Follow-up/Month 3 · Responding	1 Participants
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
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Squamous Cell Carcinoma: Postoperative Follow-up/Month 3 · Progressing	0 Participants
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
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Squamous Cell Carcinoma: Postoperative Follow-up/Month 6 · Missing	0 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Squamous Cell Carcinoma: Postoperative Follow-up/Month 6 · Responding	1 Participants
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
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Squamous Cell Carcinoma: Postoperative Follow-up/Month 6 · Progressing	1 Participants
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
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Squamous Cell Carcinoma: End of Study Visit · Missing	0 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Squamous Cell Carcinoma: End of Study Visit · Responding	0 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Squamous Cell Carcinoma: End of Study Visit · Stable/Unchanged	0 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Squamous Cell Carcinoma: End of Study Visit · Progressing	1 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Squamous Cell Carcinoma: End of Study Visit · Not Evaluable	0 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Adenocarcinoma: At Time of Surgery · Missing	0 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Adenocarcinoma: At Time of Surgery · Responding	17 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Adenocarcinoma: At Time of Surgery · Stable/Unchanged	5 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Adenocarcinoma: At Time of Surgery · Progressing	1 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Adenocarcinoma: At Time of Surgery · Not Evaluable	1 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Adenocarcinoma: Postoperative Follow-up/Month 3 · Missing	2 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Adenocarcinoma: Postoperative Follow-up/Month 3 · Responding	8 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Adenocarcinoma: Postoperative Follow-up/Month 3 · Stable/Unchanged	2 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Adenocarcinoma: Postoperative Follow-up/Month 3 · Progressing	1 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Adenocarcinoma: Postoperative Follow-up/Month 3 · Not Evaluable	2 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Adenocarcinoma: Postoperative Follow-up/Month 6 · Missing	3 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Adenocarcinoma: Postoperative Follow-up/Month 6 · Responding	5 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Adenocarcinoma: Postoperative Follow-up/Month 6 · Stable/Unchanged	1 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Adenocarcinoma: Postoperative Follow-up/Month 6 · Progressing	1 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Adenocarcinoma: Postoperative Follow-up/Month 6 · Not Evaluable	0 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Adenocarcinoma: End of Study Visit · Missing	2 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Adenocarcinoma: End of Study Visit · Responding	2 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Adenocarcinoma: End of Study Visit · Stable/Unchanged	0 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Adenocarcinoma: End of Study Visit · Progressing	2 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Histologic Subgroup Adenocarcinoma: End of Study Visit · Not Evaluable	2 Participants

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Sotigalimab With SOC ChemoRT n=29 Participants 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.
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup GE Junction: At Time of Surgery · Missing	0 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup GE Junction: At Time of Surgery · Responding	10 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup GE Junction: At Time of Surgery · Stable/Unchanged	3 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup GE Junction: At Time of Surgery · Progressing	1 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup GE Junction: At Time of Surgery · Not Evaluable	0 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup GE Junction: Postoperative Follow-up/Month 3 · Missing	2 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup GE Junction: Postoperative Follow-up/Month 3 · Responding	4 Participants
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
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup GE Junction: Postoperative Follow-up/Month 3 · Progressing	0 Participants
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
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup GE Junction: Postoperative Follow-up/Month 6 · Missing	2 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup GE Junction: Postoperative Follow-up/Month 6 · Responding	1 Participants
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
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup GE Junction: Postoperative Follow-up/Month 6 · Progressing	1 Participants
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
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup GE Junction: End of Study Visit · Missing	1 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup GE Junction: End of Study Visit · Responding	1 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup GE Junction: End of Study Visit · Stable/Unchanged	0 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup GE Junction: End of Study Visit · Progressing	3 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup GE Junction: End of Study Visit · Not Evaluable	0 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup Non-GE Junction: At Time of Surgery · Missing	0 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup Non-GE Junction: At Time of Surgery · Responding	12 Participants
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
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup Non-GE Junction: At Time of Surgery · Progressing	0 Participants
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
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
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
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
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
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
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
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
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
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
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
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup Non-GE Junction: End of Study Visit · Missing	1 Participants
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup Non-GE Junction: End of Study Visit · Responding	1 Participants
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
Radiographic/Metabolic Response to Neoadjuvant Treatment on CT-PET by Baseline Tumor Location Subgroup Non-GE Junction: End of Study Visit · Progressing	0 Participants
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 outcome

Timeframe: Up to approximately 20 weeks

Population: Safety Population: All participants who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy.

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.

Outcome measures

Measure

Sotigalimab With SOC ChemoRT n=33 Participants 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.

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

33 Participants

Adverse Events

Sotigalimab With SOC ChemoRT

Serious events: 16 serious events

Other events: 33 other events

Deaths: 7 deaths

Serious adverse events

Measure	Sotigalimab With SOC ChemoRT n=33 participants at risk 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.
Gastrointestinal disorders Nausea	9.1% 3/33 • Number of events 3 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Gastrointestinal disorders Oesophagitis	9.1% 3/33 • Number of events 3 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Gastrointestinal disorders Vomiting	9.1% 3/33 • Number of events 3 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Gastrointestinal disorders Dysphagia	3.0% 1/33 • Number of events 1 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Gastrointestinal disorders Pneumatosis intestinalis	3.0% 1/33 • Number of events 1 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Immune system disorders Cytokine release syndrome	9.1% 3/33 • Number of events 3 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Nervous system disorders Guillain-Barre syndrome	3.0% 1/33 • Number of events 1 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Nervous system disorders Seizure	3.0% 1/33 • Number of events 1 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Nervous system disorders Toxic encephalopathy	3.0% 1/33 • Number of events 1 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
General disorders Non-cardiac chest pain	3.0% 1/33 • Number of events 2 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
General disorders Impaired healing	3.0% 1/33 • Number of events 1 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Infections and infestations Pneumonia	6.1% 2/33 • Number of events 2 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Metabolism and nutrition disorders Dehydration	6.1% 2/33 • Number of events 2 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Respiratory, thoracic and mediastinal disorders Chylothorax	3.0% 1/33 • Number of events 1 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	3.0% 1/33 • Number of events 1 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Cardiac disorders Atrial fibrillation	3.0% 1/33 • Number of events 1 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Injury, poisoning and procedural complications Hip fracture	3.0% 1/33 • Number of events 1 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	3.0% 1/33 • Number of events 1 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.

Other adverse events

Measure	Sotigalimab With SOC ChemoRT n=33 participants at risk 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.
Gastrointestinal disorders Nausea	69.7% 23/33 • Number of events 40 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Gastrointestinal disorders Constipation	48.5% 16/33 • Number of events 20 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Gastrointestinal disorders Diarrhoea	45.5% 15/33 • Number of events 21 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Gastrointestinal disorders Vomiting	39.4% 13/33 • Number of events 28 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Gastrointestinal disorders Dysphagia	33.3% 11/33 • Number of events 12 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Gastrointestinal disorders Oesophagitis	27.3% 9/33 • Number of events 9 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Gastrointestinal disorders Oesophageal pain	21.2% 7/33 • Number of events 8 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Gastrointestinal disorders Odynophagia	18.2% 6/33 • Number of events 8 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Gastrointestinal disorders Dyspepsia	12.1% 4/33 • Number of events 4 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Gastrointestinal disorders Abdominal pain	9.1% 3/33 • Number of events 5 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Gastrointestinal disorders Haematochezia	9.1% 3/33 • Number of events 3 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Gastrointestinal disorders Abdominal pain upper	6.1% 2/33 • Number of events 2 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
General disorders Fatigue	72.7% 24/33 • Number of events 41 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
General disorders Chills	48.5% 16/33 • Number of events 31 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
General disorders Pyrexia	24.2% 8/33 • Number of events 13 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
General disorders Chest discomfort	6.1% 2/33 • Number of events 2 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
General disorders Influenza like illness	6.1% 2/33 • Number of events 2 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
General disorders Non-cardiac chest pain	6.1% 2/33 • Number of events 2 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Blood and lymphatic system disorders Thrombocytopenia	45.5% 15/33 • Number of events 29 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Blood and lymphatic system disorders Leukopenia	42.4% 14/33 • Number of events 39 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Blood and lymphatic system disorders Neutropenia	42.4% 14/33 • Number of events 35 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Blood and lymphatic system disorders Anaemia	27.3% 9/33 • Number of events 17 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Blood and lymphatic system disorders Lymphopenia	15.2% 5/33 • Number of events 17 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Blood and lymphatic system disorders Leukocytosis	6.1% 2/33 • Number of events 2 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Investigations Aspartate aminotransferase increased	42.4% 14/33 • Number of events 26 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Investigations Alanine aminotransferase increased	42.4% 14/33 • Number of events 23 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Investigations Blood alkaline phosphatase increased	18.2% 6/33 • Number of events 9 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Investigations Weight decreased	12.1% 4/33 • Number of events 4 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Metabolism and nutrition disorders Hyponatraemia	27.3% 9/33 • Number of events 17 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Metabolism and nutrition disorders Dehydration	24.2% 8/33 • Number of events 9 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Metabolism and nutrition disorders Decreased appetite	24.2% 8/33 • Number of events 8 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Metabolism and nutrition disorders Hypokalaemia	18.2% 6/33 • Number of events 12 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Metabolism and nutrition disorders Hypomagnesaemia	12.1% 4/33 • Number of events 7 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Metabolism and nutrition disorders Hyperglycaemia	9.1% 3/33 • Number of events 3 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Metabolism and nutrition disorders Hypocalcaemia	6.1% 2/33 • Number of events 3 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Respiratory, thoracic and mediastinal disorders Cough	15.2% 5/33 • Number of events 6 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Respiratory, thoracic and mediastinal disorders Dyspnoea	15.2% 5/33 • Number of events 5 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Respiratory, thoracic and mediastinal disorders Dysphonia	12.1% 4/33 • Number of events 4 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Respiratory, thoracic and mediastinal disorders Epistaxis	12.1% 4/33 • Number of events 4 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	9.1% 3/33 • Number of events 3 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.1% 2/33 • Number of events 2 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Nervous system disorders Headache	21.2% 7/33 • Number of events 11 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Nervous system disorders Dizziness	6.1% 2/33 • Number of events 2 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Nervous system disorders Neuropathy peripheral	6.1% 2/33 • Number of events 2 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Nervous system disorders Peripheral sensory neuropathy	6.1% 2/33 • Number of events 2 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Injury, poisoning and procedural complications Infusion related reaction	21.2% 7/33 • Number of events 13 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Injury, poisoning and procedural complications Radiation skin injury	6.1% 2/33 • Number of events 2 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Vascular disorders Hypotension	21.2% 7/33 • Number of events 8 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Vascular disorders Flushing	9.1% 3/33 • Number of events 4 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Vascular disorders Hypertension	6.1% 2/33 • Number of events 2 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Skin and subcutaneous tissue disorders Pruritus	15.2% 5/33 • Number of events 5 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Skin and subcutaneous tissue disorders Alopecia	12.1% 4/33 • Number of events 4 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Skin and subcutaneous tissue disorders Rash	9.1% 3/33 • Number of events 3 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Skin and subcutaneous tissue disorders Night sweats	6.1% 2/33 • Number of events 3 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Musculoskeletal and connective tissue disorders Arthralgia	12.1% 4/33 • Number of events 6 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Musculoskeletal and connective tissue disorders Myalgia	9.1% 3/33 • Number of events 5 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Musculoskeletal and connective tissue disorders Back pain	6.1% 2/33 • Number of events 4 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Immune system disorders Cytokine release syndrome	24.2% 8/33 • Number of events 12 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.
Hepatobiliary disorders Hyperbilirubinaemia	12.1% 4/33 • Number of events 4 • All-cause mortality was collected from enrollment to completion of the overall survival follow-up period; approximately 28 months. Adverse events were collected from the first infusion of study treatment until 100 days after receiving the last dose of study treatment, death, or initiation of new anticancer therapy, whichever occurs first; up to approximately 20 weeks. All-cause mortality was collected for all participants enrolled/randomized in the study. Adverse events were collected for all participants in the Safety Population who received at least one dose of sotigalimab and scheduled SOC of chemoradiation therapy. Adverse events are presented regardless of causal relationship to any of the study treatments.

Additional Information

Pyxis Oncology Clinical Operations

Pyxis Oncology, Inc.

Phone: (339) 545 8252

Email: clinicaltrials@pyxisoncology.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place