Trial Outcomes & Findings for A Phase 2 Study to Assess the Safety and Efficacy of IMO-2125 With 8 mg Ipilimumab in Patients With Metastatic Melanoma (NCT NCT02644967)

Last Updated: 2022-08-03

Results Overview

The following combined analysis populations were used for outcome measures (efficacy analysis N=53): * The Phase 2, 8 mg Tilso/Ipi efficacy evaluable population (N=44) * The Phase 1, 8 mg Tilso/Ipi evaluable population (N=9) The ORR for 49 evaluable (4 non-evaluable) participants who received the recommended Phase 2 dose (RP2D) of 8 mg Tilso/Ipi was calculated using the participant's best overall response (BOR). Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target lesions as assessed by MRI, CT or X-ray: Complete Response (CR) - disappearance of all target lesions; Partial Response (PR) - \>=30% decrease from baseline of the sum of diameters of all target lesions; Stable Disease (SD) - does not qualify for CR, PR or Progression; Progressive Disease (PD) - 20% increase in the sum of diameters of target lesions. Overall Response = CR or PR

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

53 participants

Primary outcome timeframe

33 weeks (29 weeks of treatment, 4 weeks follow up)

Results posted on

2022-08-03

Participant Flow

The Phase 2 study was conducted at nine (9) academic cancer centers.

In the Phase 2 study, all participants were assigned to a single arm and received IMO-2125 (tilsotolimod \[tilso\]) at the recommended Phase 2 dose (RP2D) of 8 mg, in combination with ipilimumab (ipi).

Participant milestones

Participant milestones
Measure	Phase 2, 8 mg Tilso/Ipi IMO-2125 (tilso) intratumoral injection plus ipilimumab (ipi) IMO-2125 (tilso): Drug: IMO-2125 (tilso) (8 mg as the RP2D) Intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 17, 23, and 29. Ipilimumab (ipi): 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 2, 5, 8, and 11.
Overall Study STARTED	53
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 2, 8 mg Tilso/Ipi IMO-2125 (tilso) intratumoral injection plus ipilimumab (ipi) IMO-2125 (tilso): Drug: IMO-2125 (tilso) (8 mg as the RP2D) Intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 17, 23, and 29. Ipilimumab (ipi): 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 2, 5, 8, and 11.
Overall Study Death	26
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	2
Overall Study Protocol Violation	1
Overall Study Progressive Disease	1
Overall Study Study Terminated by Sponsor	4

Baseline Characteristics

Not done for four participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 2, 8 mg Tilso/Ipi n=53 Participants IMO-2125 intratumoral injection plus ipilimumab IMO-2125: Drug: IMO-2125 (8 mg as the RP2D) Intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 17, 23, and 29. Ipilimumab: 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 2, 5, 8, and 11.
Age, Continuous	64.6 years STANDARD_DEVIATION 11.3 • n=53 Participants
Sex: Female, Male Female	20 Participants n=53 Participants
Sex: Female, Male Male	33 Participants n=53 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=53 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=53 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=53 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=53 Participants
Race (NIH/OMB) Asian	1 Participants n=53 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=53 Participants
Race (NIH/OMB) Black or African American	1 Participants n=53 Participants
Race (NIH/OMB) White	47 Participants n=53 Participants
Race (NIH/OMB) More than one race	0 Participants n=53 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=53 Participants
Region of Enrollment United States	53 participants n=53 Participants
Body Mass Index	28.9 kg/m^2 STANDARD_DEVIATION 6.4 • n=49 Participants • Not done for four participants.
Baseline Melanoma Characteristics Primary Histology - Cutaneous	42 Participants n=53 Participants
Baseline Melanoma Characteristics Primary Histology - Mucosal	5 Participants n=53 Participants
Baseline Melanoma Characteristics Primary Histology - Other	6 Participants n=53 Participants
Baseline Melanoma Stage IIIA	2 Participants n=53 Participants
Baseline Melanoma Stage IIIB	2 Participants n=53 Participants
Baseline Melanoma Stage IIIC	13 Participants n=53 Participants
Baseline Melanoma Stage IVM1A	7 Participants n=53 Participants
Baseline Melanoma Stage IVM1B	6 Participants n=53 Participants
Baseline Melanoma Stage IVM1C	22 Participants n=53 Participants
Baseline Melanoma Stage Other: IV	1 Participants n=53 Participants
Baseline Brain Metastases Yes	2 Participants n=53 Participants
Baseline Brain Metastases No	49 Participants n=53 Participants
Baseline Brain Metastases Unknown	2 Participants n=53 Participants
Baseline Visceral Metastases Yes	26 Participants n=53 Participants
Baseline Visceral Metastases No	23 Participants n=53 Participants
Baseline Visceral Metastases Unknown	4 Participants n=53 Participants
Baseline Elevated LDH Yes	14 Participants n=53 Participants
Baseline Elevated LDH No	37 Participants n=53 Participants
Baseline Elevated LDH Unknown	2 Participants n=53 Participants
Baseline BRAF Mutation Yes	23 Participants n=53 Participants
Baseline BRAF Mutation No	26 Participants n=53 Participants
Baseline BRAF Mutation Unknown	4 Participants n=53 Participants
Prior Melanoma Treatment Therapeutic Lymph Node Dissection	23 prior treatments n=53 Participants
Prior Melanoma Treatment Radiation	14 prior treatments n=53 Participants
Prior Melanoma Treatment Chemotherapy	9 prior treatments n=53 Participants
Prior Melanoma Treatment Interferon	9 prior treatments n=53 Participants
Prior Melanoma Treatment BRAF Inhibitor	9 prior treatments n=53 Participants
Prior Melanoma Treatment MEK Inhibitor	8 prior treatments n=53 Participants
Prior Melanoma Treatment CTLA-4 Inhibitor	17 prior treatments n=53 Participants
Prior Melanoma Treatment PD-(L)1 Inhibitor	49 prior treatments n=53 Participants
Prior Melanoma Treatment Other	23 prior treatments n=53 Participants

PRIMARY outcome

Timeframe: 33 weeks (29 weeks of treatment, 4 weeks follow up)

Population: Per the SAP, section 6, Analysis Populations used for efficacy, the analysis populations utilize both PIIEE (Primary Ipilimumab + IMO-2125 Efficacy Evaluable) who are ipilimumab-naive and SIIEE (Secondary Ipilumumab + IMO-2125 Efficacy Evaluable) who are not ipilumumab-naive that were treated at the RP2D, regardless of phase, and received at least one dose of each study drug.

Outcome measures

Outcome measures
Measure	Phase 2, 8 mg Tilso/Ipi n=53 Participants Arm/Group includes 9 participants rolled over from Phase 1 8mg Tilso/Ipi IMO-2125 (tilso) intratumoral injection plus ipilimumab (ipi) IMO-2125 (tilso): Drug: IMO-2125 (tilso) (8 mg as the RP2D) Intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 17, 23, and 29. Ipilimumab (ipi): 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 2, 5, 8, and 11.
Phase 2: Number of Participants With Objective Response Rate (ORR) Using RECIST v1.1 Complete Response	2 Participants
Phase 2: Number of Participants With Objective Response Rate (ORR) Using RECIST v1.1 Stable Disease	24 Participants
Phase 2: Number of Participants With Objective Response Rate (ORR) Using RECIST v1.1 Progressive Disease	14 Participants
Phase 2: Number of Participants With Objective Response Rate (ORR) Using RECIST v1.1 Non-evaluable	4 Participants
Phase 2: Number of Participants With Objective Response Rate (ORR) Using RECIST v1.1 Partial Response	9 Participants

SECONDARY outcome

Timeframe: 33 weeks (29 weeks of treatment, 4 weeks follow up)

The following combined analysis populations were used for outcome measures (efficacy analysis N=53): * The Phase 2, 8 mg Tilso/Ipi efficacy evaluable population N=40 (44 with 4 non-evaluable) * The Phase 1, 8 mg Tilso/Ipi evaluable population (N=9) Progression-free survival was defined as the number of months from the initiation of treatment to confirmed disease progression using RECIST v1.1 or death from any cause.

Outcome measures

Outcome measures
Measure	Phase 2, 8 mg Tilso/Ipi n=53 Participants Arm/Group includes 9 participants rolled over from Phase 1 8mg Tilso/Ipi IMO-2125 (tilso) intratumoral injection plus ipilimumab (ipi) IMO-2125 (tilso): Drug: IMO-2125 (tilso) (8 mg as the RP2D) Intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 17, 23, and 29. Ipilimumab (ipi): 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 2, 5, 8, and 11.
Phase 2: Progression-free Survival Participants with disease progression or death	41 Participants
Phase 2: Progression-free Survival Participants who did not progress or die	8 Participants
Phase 2: Progression-free Survival Non-evaluable	4 Participants

SECONDARY outcome

Timeframe: 6 months

The following combined analysis populations were used for outcome measures (efficacy analysis N=53): * The Phase 2, 8 mg Tilso/Ipi efficacy evaluable population N=44 (40 with 4 non-evaluable) * The Phase 1, 8 mg Tilso/Ipi evaluable population (N=9) Overall survival was defined as the number of months from initiation of treatment to death from any cause.

Outcome measures

Outcome measures
Measure	Phase 2, 8 mg Tilso/Ipi n=53 Participants Arm/Group includes 9 participants rolled over from Phase 1 8mg Tilso/Ipi IMO-2125 (tilso) intratumoral injection plus ipilimumab (ipi) IMO-2125 (tilso): Drug: IMO-2125 (tilso) (8 mg as the RP2D) Intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 17, 23, and 29. Ipilimumab (ipi): 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 2, 5, 8, and 11.
Phase 2: Overall Survival - 6 Months Participants who did not die at or before 6 months	43 Participants
Phase 2: Overall Survival - 6 Months Participants who died at or before 6 months	6 Participants
Phase 2: Overall Survival - 6 Months Non-evaluable	4 Participants

SECONDARY outcome

Timeframe: 12 months

The following combined analysis populations were used for outcome measures (efficacy analysis N=53): * The Phase 2, 8 mg Tilso/Ipi efficacy evaluable population N=40 (44 with 4 non-evaluable) * The Phase 1, 8 mg Tilso/Ipi evaluable population (N=9) Overall survival was defined as the number of months from initiation of treatment to death from any cause.

Outcome measures

Outcome measures
Measure	Phase 2, 8 mg Tilso/Ipi n=53 Participants Arm/Group includes 9 participants rolled over from Phase 1 8mg Tilso/Ipi IMO-2125 (tilso) intratumoral injection plus ipilimumab (ipi) IMO-2125 (tilso): Drug: IMO-2125 (tilso) (8 mg as the RP2D) Intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 17, 23, and 29. Ipilimumab (ipi): 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 2, 5, 8, and 11.
Phase 2: Overall Survival - 12 Months Participants who died at or before 12 months	19 Participants
Phase 2: Overall Survival - 12 Months Participants who did not die at or before 12 months	30 Participants
Phase 2: Overall Survival - 12 Months Non-evaluable	4 Participants

Adverse Events

Phase 2, 8 mg Tilso/Ipi

Serious events: 15 serious events

Other events: 52 other events

Deaths: 26 deaths

Serious adverse events

Serious adverse events
Measure	Phase 2, 8 mg Tilso/Ipi n=53 participants at risk Arm/Group includes 9 participants rolled over from Phase 1, 8 mg Tilso/Ipi. IMO-2125 intratumoral injection plus ipilimumab IMO-2125: Drug: IMO-2125 (8 mg as the RP2D) Intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 17, 23, and 29. Ipilimumab: 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 2, 5, 8, and 11.
Metabolism and nutrition disorders Hyponatraemia	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Infections and infestations Urinary tract infection	3.8% 2/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Infections and infestations Pneumonia	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Blood and lymphatic system disorders Anaemia	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Immune system disorders Anaphylactic reaction	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
General disorders Asthenia	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Gastrointestinal disorders Autoimmune colitis	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Metabolism and nutrition disorders Dehydration	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Nervous system disorders Depressed level of consciousness	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Gastrointestinal disorders Diarrhoea	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Gastrointestinal disorders Enterocolitis	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
General disorders Fatigue	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
General disorders Influenza like illness	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Gastrointestinal disorders Large intestine perforation	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin neoplasm bleeding	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Endocrine disorders Hypophysitis	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Gastrointestinal disorders Abdominal mass	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Gastrointestinal disorders Vomiting	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Gastrointestinal disorders Gastritis	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Gastrointestinal disorders Gastritis haemorrhagic	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Gastrointestinal disorders Nausea	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
General disorders Pyrexia	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Hepatobiliary disorders Autoimmune hepatitis	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Infections and infestations Clostridium difficile infection	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Infections and infestations Pleural infection	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Metabolism and nutrition disorders Failure to thrive	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Nervous system disorders Guillain-Barre syndrome	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Psychiatric disorders Confusional state	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Renal and urinary disorders Urinary retention	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Vascular disorders Hypotension	1.9% 1/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.

Other adverse events

Other adverse events
Measure	Phase 2, 8 mg Tilso/Ipi n=53 participants at risk Arm/Group includes 9 participants rolled over from Phase 1, 8 mg Tilso/Ipi. IMO-2125 intratumoral injection plus ipilimumab IMO-2125: Drug: IMO-2125 (8 mg as the RP2D) Intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 17, 23, and 29. Ipilimumab: 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 2, 5, 8, and 11.
General disorders Fatigue	56.6% 30/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
General disorders Pyrexia	34.0% 18/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
General disorders Chills	28.3% 15/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
General disorders Influenza like illness	18.9% 10/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
General disorders Injecion site pain	9.4% 5/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
General disorders Injection site reaction	7.5% 4/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
General disorders Pain	5.7% 3/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Investigations Alanine aminotransferase increased	30.2% 16/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Investigations White blood cell count decreased	24.5% 13/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Investigations Aspartate aminotransferase increased	24.5% 13/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Investigations Lymphocyte count decreased	24.5% 13/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Investigations Blood creatinine increased	17.0% 9/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Investigations Gamma-glutamyltransferase increased	17.0% 9/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Investigations Platelet count decreased	11.3% 6/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Investigations Blood alkaline phosphatase increased	9.4% 5/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Investigations Neutrophil count decreased	7.5% 4/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Metabolism and nutrition disorders Decreased appetite	24.5% 13/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Metabolism and nutrition disorders Hypertriglyceridaemia	17.0% 9/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Metabolism and nutrition disorders Hypophosphataemia	13.2% 7/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Metabolism and nutrition disorders Hyponatraemia	11.3% 6/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Metabolism and nutrition disorders Hyperglycaemia	13.2% 7/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Metabolism and nutrition disorders Hyperkalaemia	9.4% 5/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Metabolism and nutrition disorders Hypoalbumanaemia	11.3% 6/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Metabolism and nutrition disorders Hypokalaemia	11.3% 6/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Metabolism and nutrition disorders Dehydration	7.5% 4/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Metabolism and nutrition disorders Hyperuricaemia	5.7% 3/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Gastrointestinal disorders Nausea	41.5% 22/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Gastrointestinal disorders Diarrhoea	41.5% 22/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Gastrointestinal disorders Vomiting	28.3% 15/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Gastrointestinal disorders Constipation	11.3% 6/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Gastrointestinal disorders Abdominal pain	5.7% 3/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Gastrointestinal disorders Colitis	5.7% 3/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Skin and subcutaneous tissue disorders Rash	28.3% 15/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Skin and subcutaneous tissue disorders Pruritus	20.8% 11/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Skin and subcutaneous tissue disorders Rash maculo-papular	5.7% 3/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Blood and lymphatic system disorders Anaemia	35.8% 19/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Nervous system disorders Headache	30.2% 16/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Nervous system disorders Dizziness	17.0% 9/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Nervous system disorders Paraesthesia	7.5% 4/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Musculoskeletal and connective tissue disorders Arthralgia	9.4% 5/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Musculoskeletal and connective tissue disorders Muscular weakness	9.4% 5/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Musculoskeletal and connective tissue disorders Pain in extremity	7.5% 4/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Musculoskeletal and connective tissue disorders Myalgia	5.7% 3/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Infections and infestations Urinary tract infection	11.3% 6/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Respiratory, thoracic and mediastinal disorders Cough	11.3% 6/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.4% 5/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Vascular disorders Flushing	5.7% 3/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Endocrine disorders Hypophysitis	7.5% 4/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Psychiatric disorders Depression	7.5% 4/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.
Psychiatric disorders Anxiety	5.7% 3/53 • From the signing of informed consent to the end of the study (up to 12 months), which entails up to 29 weeks of treatment, a safety follow-up visit at week 32 and ongoing follow-up every 3 months until documented disease progression, new melanoma treatment, withdrawal of consent or death. Definitions aligned with FDA and ICH requirements.

Additional Information

Head of Clinical Operations

Idera Pharmaceuticals, Inc

Phone: 484-348-1605

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place