A Phase 2 interventional study of A (pembrolizumab+RT) and B (pembrolizumab) in Head and Neck Squamous Cell Carcinoma, sponsored by University of Erlangen-Nürnberg Medical School. Terminated at 7 sites in Germany. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by University of Erlangen-Nürnberg Medical School · Phase 2, Interventional, and Treatment
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Among 116 studies in Squamous Cell Carcinoma of Head and Neck with a site in Germany — 34 open to participants now, 50 under way, 14 of them phase 3. Squamous Cell Carcinoma of Head and Neck · Germany.
Among the 116 studies in Squamous Cell Carcinoma of Head and Neck with a site in Germany, this one is the 67th largest by enrollment of the 104 interventional ones that give a count, is one of 10 that started in 2018, is one of 40 in phase 2, and was the 38th registered.
2,019 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
Browse Squamous Cell Carcinoma of Head and Neck studies →34 of the 116 studies in Squamous Cell Carcinoma of Head and Neck with a site in Germany are open now. Recruiting first, the newest first:
Corbus Pharmaceuticals Inc. · Sites in Germany, United States, Austria and 11 more countries
Ages 18+
Simon Jäger · Sites in Germany
Ages 18–85
Janssen Research & Development, LLC · Sites in Germany, United States, Australia and 19 more countries
Ages 18+
Universität des Saarlandes · Sites in Germany, Switzerland
Ages 18+
University of Erlangen-Nürnberg Medical School · Sites in Germany
Ages 18+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 435 Squamous Cell Carcinoma of Head and Neck studies recruiting now, 311 (71%) set no upper age limit and 87 (20%) stop at 75 or younger; 5 take children under 18; 13 take healthy volunteers.
This study: 18 Years to 100 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
116 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 30 · Phase 2 58 · Phase 3 29
First in 1999; this study’s year is marked. 10 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 115 is above the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Median enrollment 178 across the 104 interventional studies, 331 across the 12 observational. Of the 61 that completed or were terminated, 25 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
74 of 116 have an industry lead sponsor. The 10 most frequent:
University of Erlangen-Nürnberg Medical School is the lead sponsor of 277 studies on the registry; 53 are open to participants now.
University of Erlangen-Nürnberg Medical School has 7 studies filed under Squamous Cell Carcinoma of Head and Neck — fewer than ten, so there is no comparison to draw.
10 of the studies in Squamous Cell Carcinoma of Head and Neck with a site in Germany that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06064877Phase 3AVEO Pharmaceuticals, Inc.A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma | 2027-08 |
| NCT05094336AmgenA Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101) | 2026-11-30 |
| NCT05337631University Hospital FreiburgSpecial Care Patterns for Elderly HNSCC Patients Undergoing Radiotherapy | 2026-12-31 |
| NCT05176483ExelixisStudy of Zanzalintinib in Combination With Immuno-Oncology or Other Agents in Participants With Solid Tumors | 2027-01-31 |
| NCT06367257University of Erlangen-Nürnberg Medical SchoolApp-based Recording and Optimization of the Nutritional Status in Patients With Head and Neck Tumors During and After Radio(Chemo)Therapy | 2027-04-30 |
Add all 10 to your calendar (.ics) → With an account.
Among the 116 studies in Squamous Cell Carcinoma of Head and Neck with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Randomized phase II study of immune stimulation with Pembrolizumab and radiotherapy in second line therapy of metastatic head and neck squamous cell carcinoma.
This is an open-label, randomized, prospective, multicenter phase II clinical trial of pembrolizumab with or without local radiotherapy in patients with recurrent and/or metastatic HNSCC after progression to platinum-based therapy.
All patients will receive pembrolizumab 200mg absolute dose administered every third week. Patients in treatment arm A will receive radiotherapy of one, two or three metastases with a total tumor volume of at least 10cm³ intended to induce tumor cell death acting as an in situ vaccination. Radiotherapy (RT) will be performed conventionally fractioned with single doses of 3Gy to a total dose of 36Gy. There will be a strict time schedule. Radiotherapy will always start on Wednesday. After application of the third radiation dose (Friday) the patients will receive pembrolizumab. After an interruption of radiotherapy for two days (Saturday, Sunday), radiotherapy will be continued. Pembrolizumab will be continued on an every three week schedule until confirmed disease progression according to iRECIST criteria, unacceptable toxicity, patient's wish to stop therapy or a maximal treatment time of 12 months.
Tumor assessment will be performed every 9 weeks and will be evaluated according to iRECIST and RECIST. For each patient the same assessment method will be used throughout the study. Toxicity will be assessed according to CTCAE 4.0.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible for participation in this trial, the subject must:
Female subjects of childbearing potential (Section 5.7.2) must be willing to use an adequate method of as outlined in Section 5.7.2 - Contraception, for the course of the study through 120 days after the last dose of study medication.
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
-
Exclusion Criteria:
The subject must be excluded from participating in the trial if the subject:
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., ≤ grade 1 or at baseline) from adverse events due to a previously administered agent.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Versions of RECIST adapted to particular cases. iRECIST is for immunotherapy, where a tumour can look bigger for a while before it shrinks, so growth has to be confirmed on a later scan. mRECIST usually means the version for liver cancer (hepatocellular carcinoma), which measures only the part of a tumour that still has a blood supply.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
iRECIST and mRECIST
Versions of RECIST adapted to particular cases. iRECIST is for immunotherapy, where a tumour can look bigger for a while before it shrinks, so growth has to be confirmed on a later scan. mRECIST usually means the version for liver cancer (hepatocellular carcinoma), which measures only the part of a tumour that still has a blood supply.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pembrolizumab (200mg absolute, q3w) combined with radiotherapy (12x3Gy) of one, two or three metastases.
Combination Product: A (pembrolizumab+RT)
Pembrolizumab (200mg absolute, q3w) without radiotherapy
Drug: B (pembrolizumab)
Pembrolizumab (200mg absolute, q3w) combined with radiotherapy (12x3Gy) of one, two or three metastases. Only metastases that perspectively require radiotherapy will be treated. The irradiated tumor volume must be at least 10cm³. Radiotherapy of brain metastases is not allowed.
Also known as: Keytruda + RT
Pembrolizumab (200mg absolute, q3w)
Also known as: Keytruda
Best Response According to iRECIST Criteria
Response evaluation will be performed according to iRECIST and RECIST. These iRECIST criteria are the RECIST 1.1 criteria adapted for immunotherapy. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the small
Time frame: Endpoint is the best response during pembrolizumab treatment (restaging every 9 weeks up to 12 months)
Response Rate According to RECIST
RECIST 1.1 criteria will be used to evaluate response rate
Time frame: restaging every 9 weeks up to 12 months
Assessment of the Duration of Response
The duration of the response will be evaluated in responding patients.
Time frame: restaging every 9 weeks up to 12 months
Assessment of the Progression Free Survival
progression free survival in ITT population Response evaluation will be performed according to iRECIST and RECIST. These iRECIST criteria are the RECIST 1.1 criteria adapted for immunotherapy. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time frame: restaging every 9 weeks up to 12 months
Assessment of the Overall Survival
Overall survival (in months) in ITT population
Time frame: during trial treatment an follow-up, i.e. total of 24 months
Assessment of Toxicity of the Combination of Pembrolizumab and Radiotherapy
Toxicity will be evaluated according to CTCAE 4.0 to assess toxicity of the combination of pembrolizumab and radiotherapy
Time frame: at every pembrolizumab administration (q3w) (up tp 12 months)
| Milestone | A (Pembrolizumab+RT) | B (Pembrolizumab) |
|---|---|---|
| Started | 57 | 58 |
| Completed | 57 | 58 |
| Not completed | 0 | 0 |
Response evaluation will be performed according to iRECIST and RECIST. These iRECIST criteria are the RECIST 1.1 criteria adapted for immunotherapy. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the small
| Participants | A (Pembrolizumab+RT) | B (Pembrolizumab) |
|---|---|---|
| immune complete response (iCR) | 6 | 3 |
| immune partial response (iPR) | 14 | 10 |
| immune stable disease (iSD) | 9 | 10 |
| immune progressive disease (iPD), confirmed | 5 | 10 |
| iPD, unconfirmed | 10 | 10 |
| missing iRECIST result | 0 | 3 |
| no restaging | 2 | 8 |
| not qualified for per-protocol analysis | 11 | 4 |
RECIST 1.1 criteria will be used to evaluate response rate
| Participants | A (Pembrolizumab+RT) | B (Pembrolizumab) |
|---|---|---|
| CR | 6 | 3 |
| PR | 13 | 11 |
| SD | 9 | 11 |
| PD | 19 | 21 |
| missing RECIST result | 0 | 1 |
| no restaging | 10 | 11 |
The duration of the response will be evaluated in responding patients.
| months | A (Pembrolizumab+RT) | B (Pembrolizumab) |
|---|---|---|
| Assessment of the Duration of Response | 13.65 ± 3.03 | 8.91 ± 1.80 |
progression free survival in ITT population Response evaluation will be performed according to iRECIST and RECIST. These iRECIST criteria are the RECIST 1.1 criteria adapted for immunotherapy. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
| months | A (Pembrolizumab+RT) | B (Pembrolizumab) |
|---|---|---|
| Assessment of the Progression Free Survival | 4.2 (2.1 to 10.4) | 4.0 (2.1 to 10.4) |
Overall survival (in months) in ITT population
| months | A (Pembrolizumab+RT) | B (Pembrolizumab) |
|---|---|---|
| Assessment of the Overall Survival | 11.4 (8.2 to 18.4) | 11.3 (8.6 to 19.6) |
Toxicity will be evaluated according to CTCAE 4.0 to assess toxicity of the combination of pembrolizumab and radiotherapy
| events | A (Pembrolizumab+RT) | B (Pembrolizumab) |
|---|---|---|
| total no. of adverse events | 562 | 639 |
| total no. of severe adverse events | 47 | 52 |
| no. of adverse events grade 3 to 5 | 68 | 78 |
Collected over From the time of treatment allocation/ randomization through 30 days following cessation of treatment, all AEs must be reported (i.e. up to 18 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| A (Pembrolizumab+RT) | 39/57 (68.4%) | 26/57 (45.6%) | 54/57 (94.7%) |
| B (Pembrolizumab) | 40/58 (69%) | 32/58 (55.2%) | 56/58 (96.6%) |
| Event | A (Pembrolizumab+RT) | B (Pembrolizumab) |
|---|---|---|
| DyspneaRespiratory, thoracic and mediastinal disorders | 3/57 | 7/58 |
| InfectionInfections and infestations | 4/57 | 6/58 |
| DysphagiaGastrointestinal disorders | 4/57 | 1/58 |
| PneumoniaInfections and infestations | 4/57 | 3/58 |
| AstheniaGeneral disorders | 2/57 | 0/58 |
| Tumor hemorrhageNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/57 | 2/58 |
| Device dislocationProduct Issues | 2/57 | 0/58 |
| VomitingGastrointestinal disorders | 0/57 | 2/58 |
| PyrexiaGeneral disorders | 0/57 | 2/58 |
| COVID-19Infections and infestations | 1/57 | 2/58 |
| Event | A (Pembrolizumab+RT) | B (Pembrolizumab) |
|---|---|---|
| FatigueGeneral disorders | 23/57 | 28/58 |
| Mucositis oralGastrointestinal disorders | 22/57 | 15/58 |
| PainGeneral disorders | 22/57 | 21/58 |
| Investigations - OtherInvestigations | 17/57 | 20/58 |
| NauseaGastrointestinal disorders | 14/57 | 17/58 |
| Infection and infestations - otherInfections and infestations | 16/57 | 10/58 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 16/57 | 13/58 |
| PruritusSkin and subcutaneous tissue disorders | 10/57 | 15/58 |
| ConstipationGastrointestinal disorders | 13/57 | 12/58 |
| Dry mouthGastrointestinal disorders | 12/57 | 10/58 |
| Age, Categorical(Participants) | A (Pembrolizumab+RT) | B (Pembrolizumab) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 21 | 31 | 52 |
| >=65 years | 36 | 27 | 63 |
| Age, Continuous(years) | A (Pembrolizumab+RT) | B (Pembrolizumab) | Total |
|---|---|---|---|
| Mean | 66.7 ± 9.9 | 62.8 ± 9.2 | 64.7 ± 9.7 |
| Sex: Female, Male(Participants) | A (Pembrolizumab+RT) | B (Pembrolizumab) | Total |
|---|---|---|---|
| Female | 9 | 4 | 13 |
| Male | 48 | 54 | 102 |
| Race and Ethnicity Not Collected(Participants) | A (Pembrolizumab+RT) | B (Pembrolizumab) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | A (Pembrolizumab+RT) | B (Pembrolizumab) | Total |
|---|---|---|---|
| Germany | 57 | 58 | 115 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2018 to primary completion in Oct 2024, 74 months.
Results were first posted in Mar 2026, 1 year 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Squamous Cell Carcinoma of Head and Neck →
University of Erlangen-Nürnberg Medical School →