Trial Outcomes & Findings for Immunologic Effects of CDX-301 and CDX-1140 in Resectable Pancreatic Cancer Patients (NCT NCT04536077)

NCT ID: NCT04536077

Last Updated: 2024-10-08

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 16 participants
• Primary outcome timeframe: At time of surgery (estimated to be between day 8 and day 20)
• Results posted on: 2024-10-08

Participant Flow

Participant milestones

Measure	CDX-1140 Monotherapy Patients randomized to the CDX-1140 monotherapy arm will receive a single IV infusion at a dose of 1.5 mg/kg, with surgery to follow 7-12 days after administration of CDX-1140.	CDX-1140 + CDX-301 Patients randomized to the CDX-301 + CDX-1140 arm will receive CDX-301 at 75 mcg/kg/day as a subcutaneous injection every day for 5 days (Days 1-5) with CDX-1140 IV at 1.5 mg/kg on Day 8 +/-1 day. Surgery will be 7-12 days after administration of CDX-1140.
Overall Study STARTED	8	8
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	CDX-1140 Monotherapy Patients randomized to the CDX-1140 monotherapy arm will receive a single IV infusion at a dose of 1.5 mg/kg, with surgery to follow 7-12 days after administration of CDX-1140.	CDX-1140 + CDX-301 Patients randomized to the CDX-301 + CDX-1140 arm will receive CDX-301 at 75 mcg/kg/day as a subcutaneous injection every day for 5 days (Days 1-5) with CDX-1140 IV at 1.5 mg/kg on Day 8 +/-1 day. Surgery will be 7-12 days after administration of CDX-1140.
Overall Study Did not start treatment due to surgery needing to occur urgently	1	0
Overall Study Did not start treatment due to disease progression and no longer having resectable disease	0	1

Baseline Characteristics

Immunologic Effects of CDX-301 and CDX-1140 in Resectable Pancreatic Cancer Patients

Baseline characteristics by cohort

Measure	CDX-1140 Monotherapy n=8 Participants Patients randomized to the CDX-1140 monotherapy arm will receive a single IV infusion at a dose of 1.5 mg/kg, with surgery to follow 7-12 days after administration of CDX-1140.	CDX-1140 + CDX-301 n=8 Participants Patients randomized to the CDX-301 + CDX-1140 arm will receive CDX-301 at 75 mcg/kg/day as a subcutaneous injection every day for 5 days (Days 1-5) with CDX-1140 IV at 1.5 mg/kg on Day 8 +/-1 day. Surgery will be 7-12 days after administration of CDX-1140.	Total n=16 Participants Total of all reporting groups
Age, Continuous	69 years n=5 Participants	64 years n=7 Participants	65 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: At time of surgery (estimated to be between day 8 and day 20)

Population: Participants were not included in the overall number of participants analyzed if there was insufficient tumor for additional analysis or small tumor size.

Outcome measures

Measure	CDX-1140 Monotherapy n=4 Participants Patients randomized to the CDX-1140 monotherapy arm will receive a single IV infusion at a dose of 1.5 mg/kg, with surgery to follow 7-12 days after administration of CDX-1140.	CDX-1140 + CDX-301 n=4 Participants Patients randomized to the CDX-301 + CDX-1140 arm will receive CDX-301 at 75 mcg/kg/day as a subcutaneous injection every day for 5 days (Days 1-5) with CDX-1140 IV at 1.5 mg/kg on Day 8 +/-1 day. Surgery will be 7-12 days after administration of CDX-1140.
Amount of Intratumoral Conventional Dendritic Cells (cDCs)	0.9615 percentage of total cells Standard Deviation 0.3699	2.631 percentage of total cells Standard Deviation 0.8024

Adverse Events

CDX-1140 Monotherapy

Serious events: 1 serious events

Other events: 7 other events

Deaths: 2 deaths

CDX-1140 + CDX-301

Serious events: 3 serious events

Other events: 7 other events

Deaths: 3 deaths

Serious adverse events

Measure	CDX-1140 Monotherapy n=7 participants at risk Patients randomized to the CDX-1140 monotherapy arm will receive a single IV infusion at a dose of 1.5 mg/kg, with surgery to follow 7-12 days after administration of CDX-1140.	CDX-1140 + CDX-301 n=7 participants at risk Patients randomized to the CDX-301 + CDX-1140 arm will receive CDX-301 at 75 mcg/kg/day as a subcutaneous injection every day for 5 days (Days 1-5) with CDX-1140 IV at 1.5 mg/kg on Day 8 +/-1 day. Surgery will be 7-12 days after administration of CDX-1140.
Gastrointestinal disorders Nausea	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Gastrointestinal disorders Vomiting	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
General disorders Flu like symptoms	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Disease progression	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.

Other adverse events

Measure	CDX-1140 Monotherapy n=7 participants at risk Patients randomized to the CDX-1140 monotherapy arm will receive a single IV infusion at a dose of 1.5 mg/kg, with surgery to follow 7-12 days after administration of CDX-1140.	CDX-1140 + CDX-301 n=7 participants at risk Patients randomized to the CDX-301 + CDX-1140 arm will receive CDX-301 at 75 mcg/kg/day as a subcutaneous injection every day for 5 days (Days 1-5) with CDX-1140 IV at 1.5 mg/kg on Day 8 +/-1 day. Surgery will be 7-12 days after administration of CDX-1140.
Blood and lymphatic system disorders Anemia	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Gastrointestinal disorders Diarrhea	71.4% 5/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	28.6% 2/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Gastrointestinal disorders Mucositis oral	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Gastrointestinal disorders Nausea	42.9% 3/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	42.9% 3/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Gastrointestinal disorders Vomiting	28.6% 2/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
General disorders Mouth sores - lower lip	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
General disorders Chills	28.6% 2/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	42.9% 3/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
General disorders Edema limbs	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
General disorders Fatigue	57.1% 4/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	42.9% 3/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
General disorders Fever	28.6% 2/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	42.9% 3/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
General disorders Malaise	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Investigations Alanine aminotransferase increased	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	42.9% 3/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Investigations Alkaline phosphatase increased	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Investigations Aspartate aminotransferase increased	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	42.9% 3/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Investigations Lymphocyte count decreased	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Investigations Platelet count decreased	28.6% 2/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	28.6% 2/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Metabolism and nutrition disorders Anorexia	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Metabolism and nutrition disorders Hypokalemia	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Metabolism and nutrition disorders Hyponatremia	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Musculoskeletal and connective tissue disorders Joint inflammation ankles	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Musculoskeletal and connective tissue disorders Joint inflammation bilateral hands	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Musculoskeletal and connective tissue disorders Arthralgia	85.7% 6/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	42.9% 3/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Musculoskeletal and connective tissue disorders Myalgia	42.9% 3/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	57.1% 4/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Nervous system disorders Dizziness	28.6% 2/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Nervous system disorders Headache	28.6% 2/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	57.1% 4/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Respiratory, thoracic and mediastinal disorders Nasal congestion	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Respiratory, thoracic and mediastinal disorders Sore throat	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	28.6% 2/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Skin and subcutaneous tissue disorders Red rash	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Skin and subcutaneous tissue disorders Pruritus	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Skin and subcutaneous tissue disorders Rash maculo-papular	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Ear and labyrinth disorders Ear pain	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Gastrointestinal disorders Abdominal pain	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Gastrointestinal disorders Dry mouth	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Gastrointestinal disorders Stomach pain	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
General disorders Flu like symptoms	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Infections and infestations Thrush	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Investigations Immature granulocyte increased	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Investigations Monocyte increased	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Investigations Creatinine increased	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	28.6% 2/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.
Vascular disorders Thromboembolic event	0.00% 0/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.	14.3% 1/7 • Adverse events were collected from start of treatment through time of surgery (or 60 days after end of treatment if surgery doesn't take place). If patients did not start treatment with CDX-1140 monotherapy or CDX-1140 + CDX-301 treatment then adverse events were not collected. There was one participant in each arm who did not start treatment, therefore, adverse events were not collected on those two patients.

Additional Information

Roheena Z. Panni, M.D.

Washington University School of Medicine

Phone: 314-362-7046

Email: roheenazpanni@wustl.edu

Results disclosure agreements

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